Connection and alignment detection systems and methods

ABSTRACT

A medical device includes a first housing portion (FHP) and a second housing portion (SHP) configured to be to be movable relative to each other from a first position to operatively engage at a second position to couple at least one of a drive device and a needle-inserting device supported by one of the FHP and the SHP to a reservoir supported by the other of the FHP and the SHP. Electronic circuitry configured to detect at least one of a first magnetic interaction between a magnet and at least one of a first magnetically attractive material and a first magnet-responsive device and a second magnetic interaction between the magnet and at least one of a second magnetically attractive material and a second magnet-responsive device, and to provide a signal or a change in state in response to detecting at least one of the interactions.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Continuation of U.S. application Ser. No.13/791,773, filed Mar. 8, 2013, which is a Continuation of applicationSer. No. 13/235,288, filed Sep. 16, 2011 (U.S. Pat. No. 8,435,209),which is a Continuation-In-Part of U.S. application Ser. No. 12/649,619,filed Dec. 30, 2009 (U.S. Pat. No. 8,308,679) and a Continuation-In-Partof U.S. application Ser. No. 13/103,014, filed May 6, 2011 (U.S. Pat.No. 9,421,321), which is a Continuation-In-Part of U.S. application Ser.No. 12/650,378, filed Dec. 30, 2009 (U.S. Pat. No. 8,998,840) and claimsthe benefit of U.S. Provisional Application No. 61/332,318, filed May 7,2010, which are incorporated herein by reference in their entirety.

BACKGROUND

1. Field of the Invention

Embodiments of the present invention generally relate to medical devicesystems and methods, and, in specific embodiments, such systems andmethods that include connection and/or alignment features forconnecting, aligning, and/or detecting thereof components of medicaldevice systems.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices designed to be carried by a patient, or the like. Externalpump-type delivery devices may contain reservoirs of fluidic media, suchas, but is not limited to, insulin.

External pump-type delivery devices may be connected in fluid flowcommunication to a patient or user-patient, for example, throughsuitable hollow tubing. The hollow tubing may be connected to a hollowneedle that is designed to pierce the skin of the patient and to deliverfluidic media there through. Alternatively, the hollow tubing may beconnected directly to the patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inU.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled“Infusion Device And Method With Disposable Portion” and Published PCTApplication WO 01/70307 (PCT/US01/09139) titled “Exchangeable ElectronicCards For Infusion Devices” (each of which is owned by the assignee ofthe present invention), Published PCT Application WO 04/030716(PCT/US2003/028769) titled “Components And Methods For Patient InfusionDevice,” Published PCT Application WO 04/030717 (PCT/US2003/029019)titled “Dispenser Components And Methods For Infusion Device,” U.S.Patent Application Publication No. 2005/0065760 titled “Method ForAdvising Patients Concerning Doses Of Insulin,” and U.S. Pat. No.6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each ofwhich is incorporated herein by reference in its entirety.

External pump-type delivery devices may be connected in fluid-flowcommunication to a patient-user, for example, through suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the patient-user's skin and deliver an infusionmedium to the patient-user. Alternatively, the hollow tubing may beconnected directly to the patient-user as or through a cannula or set ofmicro-needles.

In contexts in which the hollow tubing is connected to the patient-userthrough a hollow needle that pierces skin of the user-patient, a manualinsertion of the needle into the patient-user can be somewhat traumaticto the user-patient. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the user-patient, whereby a needleis forced by a spring to move quickly from a retracted position into anextended position. As the needle is moved into the extended position,the needle is quickly forced through the skin of the user-patient in asingle, relatively abrupt motion that can be less traumatic to certainuser-patients as compared to a slower, manual insertion of a needle.While a quick thrust of the needle into the skin of the user-patient maybe less traumatic to some user-patients than a manual insertion, it isbelieved that, in some contexts, some user-patients may feel less traumaif the needle is moved a very slow, steady pace.

Examples of insertion mechanisms that may be used with and may be builtinto a delivery device are described in: U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, titled “Infusion Medium Deliverysystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; and U.S. patent application Ser. No. 11/211,095,filed Aug. 23, 2005, titled “Infusion Device And Method With DisposablePortion” (each of which is assigned to the assignee of the presentinvention), each of which is incorporated herein by reference in itsentirety. Other examples of insertion tools are described in U.S. PatentApplication Publication No. 2002/0022855, titled “Insertion Device ForAn Insertion Set And Method Of Using The Same” (assigned to the assigneeof the present invention), which is incorporated herein by reference inits entirety. Other examples of needle/cannula insertion tools that maybe used (or modified for use) to insert a needle and/or cannula, aredescribed in, for example U.S. patent application Ser. No. 10/389,132filed Mar. 14, 2003, and entitled “Auto Insertion Device For SilhouetteOr Similar Products,” and/or U.S. patent application Ser. No. 10/314,653filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set andMethod of Using the Same,” both of which are incorporated herein byreference in their entirety. Further examples of various insertion toolsare described in, but are not limited to, U.S. patent application Ser.No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; U.S. patent application Ser. No. 11/646,052, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,” all of which are herein incorporated by reference intheir entirety.

Pump-type delivery devices can allow accurate doses of insulin to becalculated and delivered automatically to a patient-user at any timeduring the day or night. Furthermore, when used in conjunction withglucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of infusion medium atappropriate times of need, based on sensed or monitored levels of bloodglucose.

Pump-type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and as doctors and patient-usersbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

A medical device for treating a user includes, but is not limited to, afirst housing portion, a second housing portion, a reservoir, at leastone of a drive device and a needle-inserting device, a magnet, at leastone of a first magnetically attractive material and a firstmagnet-responsive device, at least one of a second magneticallyattractive material and a second magnet-responsive device, andelectronic circuitry.

The first housing portion is adapted to be carried by a user. The secondhousing portion is configured to be selectively operatively engaged withand disengaged from the first housing portion. The first housing portionand the second housing portion are configured to be movable relative toeach other from a first position to a second position to operativelyengage each other at the second position. The reservoir is supported byone of the first and second housing portions. The at least one of adrive device and a needle-inserting device is supported by the other ofthe first housing portion and the second housing portion relative to thehousing portion that supports the reservoir, such that upon the firsthousing portion and the second housing portion being operatively engagedat the second position, the reservoir is operatively coupled to the atleast one of the drive device and the needle-inserting device. Themagnet is supported on the first housing portion. The at least one of afirst magnetically attractive material and a first magnet-responsivedevice is supported on the second housing portion in a position tomagnetically interact with the magnet when the first housing portion andthe second housing portion are in the first position. The at least oneof a second magnetically attractive material and a secondmagnet-responsive device is supported on the second housing portion in aposition to magnetically interact with the magnet, upon the firsthousing portion and the second housing portion being operatively engagedat the second position. The electronic circuitry is configured to detectat least one of a first magnetic interaction between the magnet and theat least one of a first magnetically attractive material and a firstmagnet-responsive device, and a second magnetic interaction between themagnet and the at least one of a second magnetically attractive materialand a second magnet-responsive device. The circuitry configured toprovide a signal or a change in state in response to detection of atleast one of the first magnetic interaction and the second magneticinteraction.

In various embodiments, the at least one of a first magneticallyattractive material and a magnet-responsive device comprises amagnetically attractive material that is attracted to the magnet whenthe first housing portion and the second housing portion are in thefirst position.

In further embodiments, the at least one of a secondmagnetically-attractive material and a magnet-responsive devicecomprises a magnet-responsive device that provides the signal or changesthe state, upon the first housing portion and the second housing portionbeing operatively engaged at the second position.

In various embodiments, the at least one of a second magneticallyattractive material and a magnet-responsive device comprises amagnet-responsive device that provides the signal or changes the state,upon the first housing portion and the second housing portion beingoperatively engaged at the second position.

In some embodiments, the device further includes a user-perceptibleindicator operatively coupled to the magnet-responsive device forproviding a user-perceptible indication in response to the signal orchange in the state of the magnet-responsive device upon the firsthousing portion and the second housing portion being operatively engagedat the second position.

In further embodiments, the user-perceptible indication comprises atleast one of an audible indication, a visual indication, and a tactileindication.

In some embodiments, the at least one of a drive device and aneedle-inserting device comprises a drive device for selectively drivingfluid from the reservoir. The delivery device further includes controlelectronics operatively coupled to the magnet-responsive device forcontrolling the drive device dependent upon the signal from or state ofthe magnet-responsive device.

In further embodiments, the control electronics is configured to inhibitoperation of the drive device unless the signal from or state of themagnet-responsive device corresponds to the signal or state when thefirst housing portion and the second housing portion are operativelyengaged at the second position.

In some embodiments, the magnet has at least one of a certain magneticfield and a certain magnetic strength. The magnetic-responsive devicecomprises a sensor for detecting at least one of the certain magneticfield and the certain magnetic strength. The device further includingelectronic circuitry configured to provide a first signal in a casewhere the first housing portion and the second housing portion areoperatively engaged at the second position and the sensor detects atleast one of the certain magnetic field and the certain magneticstrength of the magnet. The electronic circuitry is further configuredto provide a second signal in a case where the first housing portion andthe second housing portion are operatively engaged at the secondposition and the sensor detects at least one of a magnetic fielddifferent from the certain magnetic field and a magnetic strengthdifferent from the certain magnetic strength of the magnet.

In further embodiments, the sensor is configured to provide a signal foractivating control circuitry of the drive device in a case where thesensor detects a gauss level exceeding a pre-defined threshold value.

In various embodiments, the reservoir supports one of the magnet and theat least one of a second magnetically attractive material and a secondmagnet-responsive device. The at least one of a drive device and aneedle-inserting device supports the other of the one of the magnet andthe at least one of a second magnetically attractive material and asecond magnet-responsive device in a position to interact with eachother when the reservoir is operatively coupled to the at least one ofthe drive device and the needle-inserting device upon the first housingportion and the second housing portion being operatively engaged at thesecond position.

In various embodiments, the magnet and the at least one of a firstmagnetically attractive material and a first magnet-responsive deviceare configured to be magnetically interactable with each other in a casewhere the first housing portion and the second housing portion areoperatively engaged and positioned relative to each other in apredetermined manner.

In some embodiments, the first housing portion and the second housingportion are positioned relative to each other in a predetermined mannerin a case where the first housing portion and the second housing portionare aligned in more than one dimension.

In some embodiments, the first housing portion and the second housingportion are positioned relative to each other in a predetermined mannerin a case where the magnet and the at least one of a first magneticallyattractive material and a first magnet-responsive device aresufficiently proximate to each other.

In various embodiments, the magnet and the at least one of a firstmagnetically-attractive material and a first magnet-responsive deviceare configured to be interactable with each other in a case where thefirst housing portion and the second housing portion are operativelyengaged and the magnet and the at least one of a firstmagnetically-attractive material and a first magnet-responsive deviceare sufficiently proximate to each other.

In some embodiments, the magnet and the at least one of a firstmagnetically attractive material and a first magnet-responsive deviceare sufficiently proximate to each other in a case where the magnet andthe at least one of a first magnetically attractive material and a firstmagnet-responsive device contact each other.

In some embodiments, the magnet and the at least one of a firstmagnetically attractive material and a first magnet-responsive deviceare sufficiently proximate to each other in a case where the magnet andthe at least one of a first magnetically attractive material and a firstmagnet-responsive device are adjacent each other.

In some embodiments, the magnet and the at least one of a firstmagnetically attractive material and a first magnet-responsive deviceare sufficiently proximate to each other in a case where the magnet andthe at least one of a first magnetically attractive material and a firstmagnet-responsive device are within a predetermined distance of eachother.

A method of manufacturing a medical device for treating a user includes,but is not limited to, any one or combination of (i) adapting a firsthousing portion to be carried by a user; (ii) configuring a secondhousing portion to be selectively operatively engaged with anddisengaged from the first housing portion, the first housing portion andthe second housing portion configured to be movable relative to eachother from a first position to a second position to operatively engageeach other at the second position; (iii) supporting a reservoir by oneof the first and second housing portions; (iv) supporting at least oneof a drive device and a needle-inserting device by the other of thefirst housing portion and the second housing portion relative to thehousing portion that supports the reservoir, such that upon the firsthousing portion and the second housing portion being operatively engagedat the second position, the reservoir is operatively coupled to the atleast one of the drive device and the needle-inserting device; (v)supporting a magnet on the first housing portion; (vi) supporting atleast one of a first magnetically attractive material and a firstmagnet-responsive device on the second housing portion in a position tomagnetically interact with the magnet when the first housing portion andthe second housing portion are in the first position; (vii) supportingat least one of a second magnetically attractive material and a secondmagnet-responsive device on the second housing portion in a position tomagnetically interact with the magnet, upon the first housing portionand the second housing portion being operatively engaged at the secondposition; (viii) configuring electronic circuitry to detect at least oneof a first magnetic interaction between the magnet and the at least oneof a first magnetically attractive material and a firstmagnet-responsive device, and a second magnetic interaction between themagnet and the at least one of a second magnetically attractive materialand a second magnet-responsive device; and (ix) configuring thecircuitry to provide a signal or a change in state in response todetection of at least one of the first magnetic interaction and thesecond magnetic interaction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 8 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 9 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 10A illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 10B illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 11 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 12 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 13 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 14A illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 14B illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 15A illustrates a portion of a medical device system in accordancewith an embodiment of the present invention

FIG. 15B illustrates a portion of a medical device system in accordancewith an embodiment of the present invention

FIG. 16 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 17 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 18 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 19 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 20 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 21 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 22 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 23 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 24 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 25 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 26 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 27 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 28 illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 29A illustrates a medical device system in accordance with anembodiment of the present invention;

FIG. 29B illustrates a medical device system in accordance with anembodiment of the present invention;

FIGS. 30A-30C illustrate a cutaway view of a portion of medical devicesystem in accordance with an embodiment of the present invention;

FIGS. 31A-31C illustrate a bottom down view of a portion of a medicaldevice system in accordance with an embodiment of the present invention;

FIGS. 32A-32C illustrate a portion of medical device system inaccordance with an embodiment of the present invention;

FIG. 33 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIG. 34 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIGS. 35A and 35B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 36A and 36B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 37A-37C illustrate a medical device system in accordance with anembodiment of the present invention;

FIGS. 38A-38C illustrate a medical device system in accordance with anembodiment of the present invention;

FIGS. 39A and 39B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 40A and 40B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 41A-41C illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIG. 42 illustrates a portion of a medical device system in accordancewith an embodiment of the present invention;

FIGS. 43A and 43B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 44A and 44B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 45A and 45B illustrate a portion of a medical device system inaccordance with an embodiment of the present invention;

FIGS. 46A, 46B, and 46C illustrate a medical device system in accordancewith an embodiment of the present invention;

FIGS. 47A, 47B, and 47C illustrate a medical device system in accordancewith an embodiment of the present invention;

FIG. 48 illustrates a block diagram of an electrical configuration of amedical device system in accordance with an embodiment of the presentinvention;

FIG. 49 is a flowchart illustrating a process for aligning and/orconnecting components of a medical device system in accordance with anembodiment of the present invention; and

FIGS. 50A-59B illustrate an engagement sequence of a medical devicesystem in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10may include a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, the delivery device 12, the sensing device 14, the CCD16, and computer 18 may be similar to those described in the followingU.S. patent applications that were assigned to the assignee of thepresent invention, where each of following patent applications isincorporated herein by reference in its entirety: (i) U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, “Infusion DeviceAnd Method With Disposable Portion”; (ii) U.S. patent application Ser.No. 11/515,225, filed Sep. 1, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (iii) U.S.patent application Ser. No. 11/588,875, filed Oct. 27, 2006, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (iv) U.S. patent application Ser. No. 11/588,832, filed Oct.27, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (v) U.S. patent application Ser. No.11/588,847, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Compressible Or Curved Reservoir Or Conduit”; (vi) U.S.patent application Ser. No. 11/589,323, filed Oct. 27, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (vii)U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (viii) U.S. patent application Ser. No. 11/602,052, filedNov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (ix) U.S. patent application Ser. No.11/602,428, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (x) U.S. patentapplication Ser. No. 11/602,113, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(xi) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (xii) U.S. patent application Ser. No.11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (xiii) U.S.patent application Ser. No. 11/606,703, filed Nov. 30, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (xiv)U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; (xix) U.S. patent application Ser. No. 11/759,725, filed Jun.7, 2007, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xx) U.S. patent application Ser. No.11/606,837, filed Nov. 30, 2006, “Method And Apparatus For Enhancing TheIntegrity Of An Implantable Sensor Device”; (xxi) U.S. patentapplication Ser. No. 11/702,713, filed Feb. 5, 2007, “Selective PottingFor Controlled Failure And Electronic Devices Employing The Same”;(xxii) U.S. patent application Ser. No. 11/843,601, filed Aug. 22, 2007,“System And Method For Sensor Recalibration”; (xxiii) U.S. patentapplication Ser. No. 11/868,898, filed Oct. 8, 2007, “MultilayerSubstrate”; (xxiv) U.S. patent application Ser. No. 11/964,649, filedDec. 26, 2007, “System And Methods Allowing For Reservoir Air BubbleManagement”; (xxv) U.S. patent application Ser. No. 12/111,751, filedApr. 29, 2008, “Systems And Methods For Reservoir Filling”; (xxvi) U.S.patent application Ser. No. 12/111,815, filed Apr. 29, 2008, “SystemsAnd Methods For Reservoir Air Bubble Management”; (xxvii) U.S. patentapplication Ser. No. 11/924,402, filed Oct. 25, 2007, “Sensor SubstrateAnd Method Of Fabricating Same”; (xxviii) U.S. patent application Ser.No. 11/929,428, filed Oct. 30, 2007, “Telemetry System And Method WithVariable Parameters”; (xxix) U.S. patent application Ser. No.11/965,578, filed Dec. 27, 2007, “Reservoir Pressure EqualizationSystems And Methods”; (xxx) U.S. patent application Ser. No. 12/107,580,filed Apr. 22, 2008, “Automative Filling Systems And Methods”; (xxxi)U.S. patent application Ser. No. 11/964,663, filed Dec. 26, 2007,“Medical Device With Full Options And Selective Enablement/Disablement”;(xxxii) U.S. patent application Ser. No. 10/180,732, filed Jun. 26,2002, “Communication Station And Software For Interfacing With AnInfusion Pump, Analyte Monitor, Analyte Meter, Or The Like”; (xxxiii)U.S. patent application Ser. No. 12/099,738, filed Apr. 8, 2008,“Systems And Methods Allowing For Reservoir Air Bubble Management”;(xxxiv) U.S. patent application Ser. No. 12/027,963, filed Feb. 7, 2008,“Adhesive Patch Systems And Methods”; (xxxv) U.S. patent applicationSer. No. 12/121,647, filed May 15, 2008, “Multi-Lumen Catheter”; (xxxvi)U.S. Patent Provisional Application Ser. No. 61/044,269, filed Apr. 11,2008, “Reservoir Plunger Head Systems And Methods”; (xxxvii) U.S. PatentApplication Ser. No. 61/044,292, filed Apr. 11, 2008, “Reservoir BarrierLayer Systems And Methods”; (xxxviii) U.S. Patent ProvisionalApplication Ser. No. 61/044,322, filed Apr. 11, 2008, “Reservoir SealRetainer Systems And Methods”; (xxxix) U.S. patent application Ser. No.12/179,502, filed Jul. 24, 2008, “Method For Formulating AndImmobilizing A Matrix Protein And A Matrix Protein For Use In A Sensor”;(xl) U.S. patent application Ser. No. 12/336,367, filed Dec. 16, 2008,“Needle Insertions Systems And Methods”; (xli) U.S. patent applicationSer. No. 12/166,210, filed Jul. 1, 2008, “Electronic Device ForControlled Failure”; (xlii) U.S. patent application Ser. No. 12/271,134,filed Nov. 14, 2008, “Multilayer Circuit Devices And ManufacturingMethods Using Electroplated Sacrificial Structures”; (xliii) U.S. patentapplication Ser. No. 12/171,971, filed Jul. 11, 2008, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; (xliv) U.S. patent application Ser. No.12/189,077, filed Aug. 8, 2008, “Packaging System”; (xlv) U.S. patentapplication Ser. No. 12/179,536, filed Jul. 24, 2008, “Real TimeSelf-Adjusting Calibration Algorithm”; (xlvii) U.S. patent applicationSer. No. 12/277,186, filed Nov. 24, 2008, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xlviii) U.S. patent application Ser. No.12/211,783, filed Sep. 16, 2008, “Implantable Sensor Method And System”;(xlix) U.S. patent application Ser. No. 12/247,945, filed Oct. 8, 2008,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (l) U.S. patent application Ser. No.12/360,077, filed Jan. 26, 2009, “Reservoir Barrier Layer Systems AndMethods”; (li) U.S. patent application Ser. No. 12/345,362, filed Dec.29, 2008, “Reservoir Seal Retainer Systems And Methods”; (lii) U.S.patent application Ser. No. 12/353,181, filed Jan. 13, 2009, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (liii) U.S. patent application Ser. No. 12/360,813, filedJan. 27, 2009, “Multi-Position Infusion Set Device And Process”; (liv)U.S. Patent Pub. No. US 2007/0142776 (application. Ser. No. 10/314,653),filed Dec. 9, 2002, “Insertion Device For An Insertion Set and MethodsOf Using The Same.” In other embodiments, the system 10, delivery device12, sensing device 14, CCD 16, and computer 18 may have other suitableconfigurations.

The delivery device 12 may be configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic media mayinclude a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media may include a medicine or a drug for treating a disease ora medical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediamay include a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 may include a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7.

In various embodiments, the sensing device 14 may be secured to the body5 of the user-patient 7 or embedded in the body 5 of the user-patient 7at a location that is remote from the location at which the deliverydevice 12 is secured to the body 5 of the user-patient 7. In variousother embodiments, the sensing device 14 may be incorporated within thedelivery device 12. In other embodiments, the sensing device 14 may beseparate and apart from the delivery device, and may be, for example,part of the CCD 16. In such embodiments, the sensing device 14 may beconfigured to receive a biological sample, analyte, or the like, tomeasure a condition of the user-patient 7.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In some embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. In addition, in variousembodiments, the delivery device 12 and/or the sensing device 14 may beconfigured to transmit data to the CCD 16 and/or the computer 18 fordisplay or processing of the data by the CCD 16 and/or the computer 18.

In some embodiments, the sensing device 14 may be integrated into theCCD 16. Such embodiments may allow the user-patient to monitor acondition by providing, for example, a sample of his or her blood to thesensing device 14 to assess his or her condition. In some embodiments,the sensing device 14 and the CCD 16 may be for determining glucoselevels in the blood and/or body fluids of the user-patient without theuse of, or necessity of, a wire or cable connection between the deliverydevice 12 and the sensing device 14 and/or the CCD 16.

In some embodiments, the CCD 16 may be for providing information to theuser-patient that facilitates the user-patient's subsequent use of adrug delivery system. For example, the CCD 16 may provide information tothe user-patient to allow the user-patient to determine the rate or doseof medication to be administered into the body of the user-patient. Inother embodiments, the CCD 16 may provide information to the deliverydevice 12 to control the rate or dose of medication administered intothe body of the user-patient

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same,” all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention may include a disposable housing 20,a durable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 may support thereservoir system 40 and has a bottom surface (facing downward and intothe page in FIG. 2) configured to secure to the body of theuser-patient. An adhesive may be employed at an interface between thebottom surface of the disposable housing 20 and the skin of theuser-patient to adhere the disposable housing 20 to the skin of theuser-patient. In various embodiments, the adhesive may be provided onthe bottom surface of the disposable housing 20, with a peelable coverlayer covering the adhesive material. In this manner, the cover layermay be peeled off to expose the adhesive material, and the adhesive sideof the disposable housing 20 may be placed against the user-patient, forexample against the skin of the user-patient. Thus in some embodiments,the delivery device 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12, and delivery devices in general,may include, but is not limited to, the MiniMed Paradigm 522 InsulinPump, MiniMed Paradigm 722 Insulin Pump, MiniMed Paradigm 515 InsulinPump, MiniMed Paradigm 715 Insulin Pump, MiniMed Paradigm 512R InsulinPump, MiniMed Paradigm 712R Insulin Pump, MiniMed 508 Insulin Pump,MiniMed 508R Insulin Pump, and any other derivatives thereof.

The reservoir system 40 may be configured for containing or holdingfluidic media, such as, but not limited to insulin. In variousembodiments, the reservoir system 40 may include a hollow interiorvolume for receiving fluidic media, such as, but not limited to, acylinder-shaped volume, a tubular-shaped volume, or the like. In someembodiments, the reservoir system 40 may be provided as a cartridge orcanister for containing fluidic media. In various embodiments, thereservoir system 40 can be refilled with fluidic media. In furtherembodiments, the reservoir system 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 may include at least oneport 41 for allowing fluidic media to flow into and/or flow out of theinterior volume of the reservoir system 40. In some embodiments, theinfusion path 50 may include a connector 56, a tube 54, and a needleapparatus 52. The connector 56 of the infusion path 50 may beconnectable to the port 41 of the reservoir system 40. In variousembodiments, the disposable housing 20 may be configured with an openingnear the port 41 of the reservoir system 40 for allowing the connector56 of the infusion path 50 to be selectively connected to anddisconnected from the port 41 of the reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 may becovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. In addition, invarious embodiments, the connector 56 of the infusion path 50 mayinclude a needle for piercing the septum covering the port 41 of thereservoir system 40 to allow fluidic media to flow out of the interiorvolume of the reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector,” which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 may include a needle that is ableto puncture the skin of the user-patient. In addition, in variousembodiments, the tube 54 connects the connector 56 with the needleapparatus 52 and may be hollow, such that the infusion path 50 is ableto provide a path to allow for the delivery of fluidic media from thereservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures that allow the two parts to connect together easily, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20 to provide aseal against water entering between the durable housing 30 and thedisposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection to move the plunger arm and the plunger head to cause fluid tobe drawn into the reservoir system 40 from a patient. The motor may bearranged within the durable housing 30 and the reservoir system 40 maybe correspondingly arranged on the disposable housing 20, such that theoperable engagement of the motor with the plunger head, through theappropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same,” which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. In addition, aflexible disposable housing 20 may result in an increase in site optionson the body of the user-patient at which the disposable housing 20 maybe secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 17 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set,” which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 may include a sensor 15 connectedby the connection element 17 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 may be configured to besecurable to a body of a user-patient. The reservoir-retaining portion24 of the disposable housing 20 is configured to house the reservoirsystem 40. The reservoir-retaining portion 24 of the disposable housing20 may be configured to have an opening to allow for the port 41 of thereservoir system 40 to be accessed from outside of thereservoir-retaining portion 24 while the reservoir system 40 is housedin the reservoir-retaining portion 24. The durable housing 30 may beconfigured to be attachable to and detachable from the base 21 of thedisposable housing 20. The delivery device 12 in the embodimentillustrated in FIG. 3 includes a plunger arm 60 that is connected to orthat is connectable to a plunger head (not shown in FIG. 3) within thereservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir-retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 may includethe durable housing 30, and a drive device 80. The drive device 80 mayinclude a motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). In addition, in various embodiments, the durable housing 30may be configured with an opening 32 for receiving a plunger arm 60(refer to FIG. 3). In addition, in various embodiments, the durablehousing 30 may include one or more connection members 34, such as tabs,insertion holes, or the like, for connecting with the base 21 of thedisposable housing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 may include the base 21 and thereservoir-retaining portion 24. In various embodiments, the base 21 mayinclude a top surface 23 having one or more connection members 26, suchas tabs, grooves, or the like, for allowing connections with the one ormore connection members 34 of embodiments of the durable housing 30(refer to FIG. 5B).

In various embodiments, the reservoir system 40 may be housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 may be configured to hold fluidic media. Inaddition, in various embodiments, the plunger head 70 may be disposed atleast partially within the reservoir system 40 and may be moveablewithin the reservoir system 40 to allow fluidic media to fill into thereservoir system 40 and to force fluidic media out of the reservoirsystem 40. In some embodiments, the plunger arm 60 may be connected toor is connectable to the plunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 may extend tooutside of the reservoir-retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 may have a mating portionfor mating with the drive device linkage portion 82 of the drive device80 (refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, the user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. In addition, in various embodiments, thereservoir system 40 may be replaced with a new reservoir (not shown),while the disposable housing 20 may be re-used with the new reservoir.In such embodiments, the new reservoir may be inserted into thedisposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 may include reservoir status circuitry (not shown),and the reservoir system 40 may include reservoir circuitry (not shown).In various embodiments, the reservoir circuitry stores information suchas, but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 may include the reservoir status circuitry (notshown), and the reservoir status circuitry may be configured to readdata from the reservoir circuitry (not shown) when the reservoir system40 is inserted into the disposable portion 9.

In various embodiments, the reservoir status circuitry (not shown) maybe further configured to store data to the reservoir circuitry after atleast some of the contents of the reservoir system 40 have beentransferred out of the reservoir system 40 to update information in thereservoir circuitry (not shown) related to an amount of contents stillremaining in the reservoir system 40. In some embodiments, the reservoirstatus circuitry (not shown) may be configured to store data to thereservoir circuitry (not shown) to update information in the reservoircircuitry (not shown) related to an amount of contents remaining in thereservoir system 40 when the reservoir system 40 is inserted into thedisposable portion 9. In some embodiments, the delivery device 12 mayinclude the reservoir status circuitry (not shown) and the reservoirsystem 40 may include the reservoir circuitry (not shown), and thereservoir status circuitry (not shown) may selectively inhibit use ofthe delivery device 12 or may selectively provide a warning signal basedon information read by the reservoir status circuitry (not shown) fromthe reservoir circuitry (not shown).

In addition, embodiments may be configured to establish a contiguousfluid flow passage for fluid transfer between a reservoir and theuser-patient when the hollow needle or cannula is inserted into theuser-patient. Needle-inserting devices according to embodiments of thepresent invention may be used with, connectable to and disconnectablefrom, or incorporated in a portion of an infusion medium deliverysystem. For example, a needle-inserting device may be connectable to abase structure of a pump-type delivery device for insertion of a needle,after which the needle-inserting device may be removed from the basestructure, whereupon a further housing portion of the delivery device(containing components such as, but not limited to, a reservoir and pumpor drive device) may be coupled to the base structure for operation.

Alternatively, the needle-inserting device may be incorporated into thefurther housing portion that contains other components as describedabove. In yet other embodiments, the needle-inserting device may beconnectable to (and releasable from) or incorporated within an injectionsite module or other housing that connects, for example, by flexibletubing, to other components of a medical device (such as, but notlimited to an infusion medium delivery device). In yet otherembodiments, needle inserter devices may be configured for use withsystems other than infusion medium delivery systems, such as, but notlimited to sensor and monitor systems, or the like.

In various embodiments, any of the connection structures described abovefor allowing one or more parts of the delivery device to be selectivelyconnectable to and separable from one or more other parts of thedelivery device may include one or more elements as will be described.The element(s) may function to provide one or more of aligningconnectable parts, connection of connectable parts, and sensing theconnection of connectable parts, as will be described.

FIGS. 7-15B illustrate a medical device system 100 according to variousembodiments of the present invention. The medical device system 100 mayinclude features similar to the medical device systems discussed in thedisclosure or employed as an embodiment of the medical devices (e.g.,delivery device 12 in FIGS. 1-6C) discussed in the disclosure. Althoughthe medical device system 100 may include features similar or used withthe embodiments of FIGS. 1-6C, it should be understood that the medicaldevice system 100 may also include some or all of the same features andoperate in a manner similar to that shown and described in theembodiments of FIGS. 16-32B. In addition, some or all of the featuresshown in FIGS. 1-6C and 16-32B may be combined in various ways andincluded in the embodiments shown in FIGS. 7-15B. Likewise, it should beunderstood that any of the features of the embodiments of FIGS. 7-15Bmay be combined or otherwise incorporated into any of the otherembodiments of FIGS. 7-15B as well as any other embodiment hereindiscussed.

A generalized representation of a first part 101 and a second part 102of a medical device system 100, such as, but not limited to the deliverydevice 12 in FIGS. 1-6C as described above, is shown in FIG. 7. Thefirst part 101 and the second part 102 may be configured to beconnectable to each other or to be otherwise operatively engageable witheach other. In some embodiments, a connection structure may be providedto secure the first part 101 and the second part 102 together foroperation of the medical device system 100.

In further embodiments, the connection structure may include a magneticstructure for connecting the first part 101 and the second part 102. Forexample, a magnet may be provided on one of the first part 101 and thesecond part 102 and a magnetically attractive material, such as a magnetof opposite polarity, a metal, and/or the like may be provided on theother of the first part 101 and the second part 102. Such an example aswell as other examples are disclosed in, but are not limited to, U.S.patent application Ser. No. 11/759,725, entitled “Infusion MediumDelivery Device and Method with Drive Device for Driving Plunger inReservoir,” herein incorporated by reference in its entirety.

Various embodiments, additionally or alternatively, may include othersuitable structural features to aid in connecting the first part 101 andthe second part 102. These may include, but are not limited to,adhesives, snap-fit structures, friction-fit structures, and/or the likeon the first part 101 and/or the second part 102 that abut as the firstpart 101 and the second part 102 are brought together for connection.Other examples of various connection structures can be found, but arenot limited to, U.S. patent application Ser. No. 12/553,038, filed Sep.2, 2009, entitled “Insertion Device Systems and Methods,” hereinincorporated by reference in their entirety.

The first part 101 and the second part 102 may each be one of twohousing portions, such as, but not limited to, a durable housing portion30 (e.g., FIGS. 1-6C) and a disposable housing portion 20 (e.g., FIGS.1-6C), as previously described. As previously discussed with respect toFIGS. 1-6C, the durable housing portion 30 may include variouscomponents, such as, but not limited to, a drive device 80, drive motor84, drive device linkage portion 82, and/or the like. The disposablehousing portion 20 may include various components, such as, but notlimited to, a reservoir system 40. Returning to FIG. 7, alternatively,one of the first part 101 and the second part 102 may be a base portion21 (e.g., FIGS. 1-6C) and the other of the first part 101 and the secondpart 102 may be a housing portion such as, but not limited to, thedurable housing portion 30 and/or the disposable housing portion 20. Insome embodiments, one of the housing portions may be a reservoir system40 (e.g., FIGS. 1-6C).

In further embodiments, the medical device system 100 may include morethan two housing portions. For example, such embodiments may include,but are not limited to, a durable housing portion 30, a disposablehousing portion 20, and a base portion 21. Other housing portions mayinclude, but are not limited to, an insertion device, electronics,and/or the like.

In some embodiments, one of the medical device system 100 parts (e.g.,101 in FIG. 7) may be provided with a first interactive element 104. Theother medical device system 100 part (e.g., 102 in FIG. 7) may beprovided with a second interactive element 106. The first interactiveelement 104 and the second interactive element 106 may be configured tointeract with each other when in sufficiently close proximity to eachother.

The first interactive element 104 may be arranged in a fixed relation tothe first part 101, for example, by attaching, forming, or otherwisesupporting the first interactive element 104 to a suitable location on awall or on other structure of or in the first part 101. The secondinteractive element 106 may be arranged in a fixed relation to thesecond part 102, for example, by attaching, forming, or otherwisesupporting the second interactive element 106 to a suitable location ona wall or on other structure of or in the second part 102. In someembodiments, the second interactive element 106 may be arranged on thesecond part 102 to be relative to the first interactive element 104 onthe first part 101 in a case where the first part 101 and the secondpart 102 are connected or otherwise operatively engaged and the firstpart 101 and the second part 102 are properly aligned. Accordingly, thefirst interactive element 104 and the second interactive element 106 maybe aligned. As such, the first interactive element 104 and the secondinteractive element 106, for example, may interact with each other in acase where the first part 101 and the second part 102 are connected orotherwise operatively engaged and the first interactive element 104 andthe second interactive element 106 are properly aligned.

An interaction between the first interactive element 104 and the secondinteractive element 106 (or between any other interactive elementdiscussed in the disclosure) may occur in a case where the first part101 and the second part 102 are operatively engaged properly orotherwise brought into a pre-defined, sufficiently aligned positionand/or in a pre-defined, sufficiently close proximity. The predefinedaligned position and/or proximity, for example, may correspond to aproperly aligned and mutually proximate position for connection of thefirst part 101 and the second part 102 for operation. It should beunderstood that with respect to the embodiments described in thedisclosure, operatively engaged may include connected and/or aligned,unless otherwise specified. Likewise, operatively engaged (and/orconnected and/or aligned) may include operatively engaged properly(and/or connected properly and/or aligned properly), unless otherwisespecified.

In various embodiments, the first interactive element 104 and the secondinteractive element 106 may be similar types of devices. For instance,in some embodiments, the first interactive element 104 may be configuredto interact with second interactive elements (e.g., the secondinteractive element 106) and/or the second interactive element 106 maybe configured to interact with first interactive elements (e.g., thefirst interactive element 104). For example, a first interactive element104 may be a magnet arranged to provide an N (north) polarity and asecond interactive element 106 may be a magnet arranged to provide an S(south) polarity. The first interactive element 104 may interact moreeffectively (e.g., connect and/or align) with the second interactiveelement 106 than with another first interactive element 104 arranged toprovide an N polarity.

In various embodiments, the first interactive element 104 may beconfigured to interact with second interactive elements (e.g., thesecond interactive element 106), as well as other first interactiveelements (e.g., first interactive element 104′ (e.g., FIG. 8 discussedbelow)). In some embodiments, the second interactive element 106 may beconfigured to interact with first interactive elements (e.g., the firstinteractive element 104), as well as other second interactive elements(e.g., second interactive element 106′ (e.g., FIG. 8 discussed below)).

In some embodiments, the first interactive element 104 and the secondinteractive element 106 may be dissimilar types of mechanisms. Forexample, a first interactive element 104 may be a ferrous conduit and asecond interactive element 106 may be a magnet. The second interactiveelement 106 may interact with (e.g., connect and/or align) the firstinteractive element 104, as well as other magnetic second interactiveelements 106. As another example, as described below with respect to,for example FIGS. 15A and 15B, first interactive element 204 may be aprotrusion, pusher, finger, or other structural feature configuredand/or arranged to act upon (e.g., urge) a second interactive element206′, and/or the like that may be for interacting with (e.g.,functioning as a conductor for) another second interactive element 206.

Returning to FIG. 7, in some embodiments, suitable electronics may beconnected to the first interactive element 104 and/or the secondinteractive element 106 to provide a controlled power signal toselectively activate or otherwise control one or more of the firstinteractive element 104 and the second interactive element 106 and/orother components as described in the disclosure.

In various embodiments, some or all of the interactive elements (e.g.,first interactive element 104, second interactive element 106) may beintegrated with the first part 101 and the second part 102 and/or beseparate components placed in or on the first part 101 and the secondpart. For example, the interactive elements may be placed in or on thefirst part 101 and the second part 102 in a friction-fitting manner,during a molding a process, and/or the like. In some embodiments, one ormore of the interactive elements may be insert mold labeled on itsrespective part. In some embodiments, a film cover may be provided forsupporting one or more of the interactive elements.

In various embodiments, some or all of the interactive elements may havean exposed surface. The exposed surface of the interactive elements maybe for allowing increased interactivity between each of the interactiveelements, for example to allow a user to locate the interactive elements(e.g., to facilitate connection of the first part 101 and the secondpart 102), and/or the like. In other embodiments, some or all of theinteractive elements may be covered, for example (but not limited to)being disposed completely within the first part 101 and/or the secondpart 102. Such embodiments may allow for protecting the interactiveelements from damage, debris collection, mitigating interference withother components (e.g., other interactive elements, electronics in themedical device system 100, and/or the like), and/or the like.

In various embodiments, the first interactive element 104 and the secondinteractive element 106 may be properly aligned such as, but not limitedto, when the first interactive element 104 and the second interactiveelement 106 align in one dimension or more than one dimension, aresufficiently proximate to each other, contact each other, an electricalor magnetic connection is established between the components, and/or thelike. Any one or combination of these events may occur, for example, ina case where the first part 101 and the second part 102 are operativelyengaged and positioned relative to each other in a predetermined manner.In other words, the first part 101 and the second part 102 have beenconnected sufficiently properly and/or otherwise within an operatingthreshold.

In other embodiments, the first interactive element 104 may be arrangedon the first part 101 at a location to interact electronically (ormagnetically) with the second interactive element 106 in a case wherethe first part 101 and the second part 102 are brought together and thefirst interactive element 104 and the second interactive element 106 arein relative close proximity to each other, such as, but not limited to,in contact with each other. In some embodiments, suitable electronicsmay be connected to at least one of the first interactive element 104and the second interactive element 106 to provide a controlled powersignal to selectively activate or otherwise control the firstinteractive element 104 and/or the second interactive element 106.

In some embodiments, such as the embodiment exemplified in FIG. 8,multiple pairs of first interactive elements and second interactiveelements may be provided on the first part 101 and the second part 102,for example, to provide a more reliable alignment between the first part101 and the second part 102. In the illustrated embodiment, a secondpair of interactive elements including a first interactive element 104′and a second interactive element 106′ are shown as supported by thefirst part 101 and the second part 102 respectively in a manner similarto that described above for the first interactive element 104 and thesecond interactive element 106. In further embodiments, more than twopairs of interactive elements may be supported by the first part 101 andthe second part 102, as previously described.

In various embodiments, the first interactive element 104 and the firstinteractive element 104′ (and/or the second interactive element 106 andthe second interactive element 106′) may be dissimilar from each. Forinstance, in some embodiments, the first interactive element 104 may beconfigured to interact with second interactive elements (e.g., thesecond interactive element 106) and/or the first interactive element104′ may be configured to interact with second interactive elements(e.g., the second interactive element 106). For example, a firstinteractive element 104 may be a magnet arranged to provide an N (north)polarity and a second interactive element 106 may be a magnet arrangedto provide an S (south) polarity. A first interactive element 104′ maybe a magnet arranged to provide an S (south) polarity and a secondinteractive element 106′ may be a magnet arranged to provide an N(north) polarity. Thus, the first interactive element 104 may interactin a more mutually attracting manner (e.g., to connect and/or align)with the second interactive element 106 than the second interactiveelement 106′. Similarly, the first interactive element 104′ may interactin a more mutually attracting manner (e.g., to connect and/or align)with the second interactive element 106′ than the second interactiveelement 106.

Moreover, for instance, in some embodiments, the first interactiveelement 104 may be configured to interact with second interactiveelements (e.g., the second interactive element 106), as well as otherfirst interactive elements (e.g., first interactive element 104′). Insome embodiments, the second interactive element 106 may be configuredto interact with the first interactive elements (e.g., the firstinteractive element 104), as well as other second interactive elements(e.g., second interactive element 106′). For example, a firstinteractive element 104 may be a ferrous conduit and a secondinteractive element 106 may be a magnet. The second interactive element106 may interact with (e.g., connect and/or align) the first interactiveelement 104 as well as other magnetic second interactive elements 106′.

In some embodiments, the first interactive element 104 and the firstinteractive element 104′ and/or the second interactive element 106 andthe second interactive element 106′ may be dissimilar types ofmechanisms. For example, as described with respect to, for example FIGS.15A and 15B, a first interactive element 104 may be a protrusion,pusher, finger, or other structural feature configured and/or arrangedto act upon (e.g., urge) a second interactive element 106′ and/or thelike arranged and/or configured to interact with (e.g., function as aconductive medium) a second interactive element 106.

With reference to FIG. 7, thus in various embodiments, as part of aprocess of assembling a first part 101 and a second part 102 of amedical device system 100, a user may bring the first part 101 and thesecond part 102 together to operatively engage each other or otherwisebe in sufficiently close proximity. Accordingly, a first interactiveelement 104 and a second interactive element 106 (and/or a firstinteractive element 104′ and a second interactive element 106′) may beinteractable with each other to determine, for example, whether thefirst part 101 and the second part 102 have been properly aligned.

In some embodiments, the interactive elements (e.g., first interactiveelement 104, first interactive element 104′, second interactive element106, and second interactive element 106′) may be configured to help auser-patient align the first part 101 and the second part 102 relativeto each other for proper connection. For example, one or more pairs ofinteractive element 104, 106, 104′, and/or 106′ may be arranged at oneor more appropriate locations on the first part 101 and the second part102 to allow an indicator or indicator device 420 (e.g., FIG. 48)associated with the medical device system 100 to provide an indicationthat the first part 101 and the second part 102 are properly aligned inone or more dimensions relative to each other. Alternatively or inaddition, one or more pairs of interactive element 104, 106, 104′,and/or 106′ may be of suitable size(s), shape(s), orientation(s), andposition(s) to allow an indicator associated with the medical devicesystem 100 to provide an indication that the first part 101 and thesecond part 102 are properly aligned in one or more dimensions relativeto each other. For example, the indicator may provide an indication thatthe first part 101 and the second part 102 are properly connected in acase where the first interactive element 104 and the second interactiveelement 106 interact.

In some embodiments, such as the embodiment exemplified in FIG. 9, aconductive medium 108 may be at a position adjacent one of theinteractive element(s) (e.g., the second interactive element 106 in FIG.9) or otherwise in communication with the interactive element to allowthe conductive medium 108 to function as a conductor for the interactiveelement. In such embodiments, the interactive element may interact withthe conductive medium 108 to allow the conductive medium 108 to be havesimilar characteristics or properties, though not necessarily exactlythe same characteristics or properties. For example, a magnetic secondinteractive element 106 may provide a magnetic charge to a magneticconductive medium 108. The conductive medium 108 may be made of amaterial, such as, but not limited to, an electrically conductivematerial (e.g., metal, graphite, salt solutions, plasma, and/or thelike), a magnetically attractive material (e.g., metal), and/or thelike. In some embodiments, the conductive medium 108 may be asufficiently high thermally conductive material (e.g., metal, or anyother material with a thermal conductivity, for example (but not limitedto), above 1), and/or the like.

In further embodiments, the conductive medium 108 may be arranged on itsrespective part (e.g., the second part 102 in FIG. 9) to allow theinteractive element (e.g., the second interactive element 106 in FIG. 9)to be interactable with the other interactive element (e.g., the firstinteractive element 104 in FIG. 9) on the opposing part (e.g., the firstpart 101 in FIG. 9) via the conductive medium 108 in any of the mannersdescribed in the disclosure. For example, in particular embodiments, thefirst interactive element 104 may interact with the conductive medium108 in a case where the first part 101 and the second part 102 areoperatively engaged properly. Accordingly, the first interactive element104 and the second interactive element 106 may be interactable with eachother via the conductive medium 108. Thus, some embodiments may allowthe first interactive element 104 to interact with the conductive medium108 in addition to or alternative to the second interactive element 106.For example, a magnetic second interactive element 106 may magnetize amagnetically attractive conductive medium 108, which may then interactwith the first interactive element 104.

In some embodiments, the conductive medium 108 may be arranged at aposition adjacent the other interactive element (e.g., the firstinteractive element 104) or otherwise in communication with the otherinteractive element to allow the conductive medium 108 to function as aconductor for the other interactive element. In further embodiments, theconductive medium 108 may be arranged on its respective part to allowthe other interactive element to be interactable with the interactiveelement (e.g., the second interactive element 106) on the opposing partvia the conductive medium 108 in any of the manners described in thedisclosure. For example, in particular embodiments, the secondinteractive element 106 may interact with the conductive medium 108 in acase where the first part 101 and the second part 102 are operativelyengaged properly. Accordingly, the first interactive element 104 and thesecond interactive element 106 may be interactable with each other viathe conductive medium 108. Thus, some embodiments may allow for thesecond interactive element 106 to interact with the conductive medium108 in addition to or alternative to the first interactive element 106.For example, an electrical connection between the first interactiveelement 104 and the second interactive element 106 may be established bycontacting the conductive medium 108 (e.g., electrically conductivemedium).

In some embodiments, the indicator may be configured to provide anindication corresponding to a type of alignment, for example, that amaximum alignment or a minimum required alignment has been achievedbetween the first interactive element 104 and the second interactiveelement 106 during connection of the first part 101 and the second part102. In some embodiments, the indicator may be configured to provide anindication corresponding to various stages of alignment, for example, noalignment, alignment in one or more axes and misalignment in one oraxes, complete alignment, and/or misalignment after alignment, and/orthe like.

In various embodiments, additional structural features may be providedon one or both of the first part 101 and the second part 102 to providea mechanical alignment function. Such additional structural features mayinclude a first sloped surface 101 a on the first part 101 arranged tomate or otherwise engage a corresponding sloped surface 102 a on thesecond part 102. As the first part 101 and the second part 102 arebrought together, a misalignment of the first part 101 and the secondpart may result in the first sloped surface 101 a and the second slopedsurface 102 a engaging each other. Accordingly, the first sloped surface101 a and the second sloped surface 102 may engage each other in aposition at which the first sloped surface 101 a and the second slopedsurface 102 a may slide relative to each other toward a proper alignmentposition.

In some embodiments, multiple pairs of sloped surfaces may be providedon the first part 101 and the second part 102, for example, to providealignment in one or more directions and/or one or more dimensions. Forexample, in some embodiments, such as the embodiment exemplified in FIG.8, the first part 101 and the second part 102 may include a second pairof sloped surfaces including a first sloped surface 101 b and a secondsloped surface 102 b in a manner similar to that described above for thefirst sloped surface 101 a and the second sloped surface 102 a. Thesecond pair of sloped surfaces may have a similar or different sizeand/or shape than the first part of sloped surfaces.

In some embodiments, such as the embodiments exemplified in FIGS. 10Aand 10B, at least one of the first part 101 and the second part 102 mayinclude one or more sloped surfaces arranged to mate with correspondingsloped surfaces on the other of the first part 101 and the second part102. In such embodiments, at least one of the one or more slopedsurfaces may be mated with one or more of the plurality of correspondingsloped surfaces so that the first part 101 and the second part 102 canbe aligned and/or connected in multiple orientations.

In further embodiments, some or all of the interacting components, suchas the first interactive element 104 and the second interactive element106, may be arranged along the first part 101 and the second part 102 toallow the first part 101 and the second part 102 to be connected and/oraligned in multiple orientations. For example, in FIGS. 10A and 10B, thesecond part 102 may include multiple sets of second interactive elements106 and multiple sets of second interactive elements 106′, thus allowingthe first interactive element 104 to be selectively aligned with any ofthe second interactive elements 106 while allowing the first interactiveelement 104′ to be aligned with at least one of the second interactiveelements 106′. As such, the first part 101 and the second part 102 canbe aligned and/or connected in at least a first orientation (e.g., FIG.10A) and a second orientation (e.g., FIG. 10B). As another example, thefirst part 101 may include multiple sets of first interactive elements106 and multiple sets of first interactive elements 104′ for allowingselective alignment with the second interactive element 106 and thesecond interactive element 106′, respectively.

In some embodiments, such as the embodiment exemplified in FIG. 11, theinteractive elements (e.g., first interactive element 104, firstinteractive element 104′, second interactive element 106, secondinteractive element 106′, and/or the like) may be supported and/or bepart of the sloped surfaces 101 a, 102 a to provide an alignment andconnection function as described in the disclosure. Various embodimentsmay additionally or alternatively include other suitable structuralfeatures to aid in the alignment, including, but not limited to, curvedor stepped surfaces, rollers and/or the like on the first part 101 andthe second part 102 that abut as the first part 101 and the second part102 are brought together for connection. In some embodiments, one orboth of the first part 101 and the second part 102 may include amagnetic connection and/or alignment structure, such as that disclosedin U.S. patent application Ser. No. 11/759,725 entitled “Infusion MediumDelivery Device and Method with Drive Device for Driving Plunger inReservoir,” herein incorporated by reference in its entirety.

In some embodiments, such as the embodiment exemplified in FIG. 12, oneor both of the first interactive element 104 and the second interactiveelement 106 may have a mating, sloped or otherwise shaped surface forengaging and providing an alignment function when the first part 101 andthe second part 102 are brought together for connection. For example,the first interactive element 104 may have a sloped surface adapted tobe mated with a corresponding sloped surface of the second interactiveelement 106 in a manner similar to that described with respect to thefirst sloped surface 101 a (e.g., FIGS. 7-11) and the second slopedsurface 102 a (e.g., FIGS. 7-11). In further embodiments, such as theembodiment exemplified in FIG. 13, one or both of the first part 101 andthe second part 102 may include sloped surfaces 101 a, 102 a for matingwith interactive elements (e.g., first interactive element 104, secondinteractive element 106) having appropriately shaped surfaces similar tothat previously described.

In various embodiments, such as the embodiments exemplified in FIGS. 14Aand 14B, one or more of the interactive elements (e.g., firstinteractive element 104, first interactive element 104′, secondinteractive element 106, second interactive element 106′, and/or thelike) may be a spring, finger, or other bias member for contacting oneor more of the other interactive elements upon the first part 101 andthe second part 102 being operatively engaged. In such embodiments, theone or more of the interactive elements may be made of a suitably rigidmaterial, such as, but not limited to, metal, plastic, glass, compositematerials, rubber, and/or the like.

For example, as shown in FIG. 14A, the second interactive element 106may be biased toward a first position, for example an extended position.As the first part 101 and the second part 102 are brought together, thesecond interactive element 106 may be urged by a portion of the opposingpart to a second position, for example a collapsed position (e.g., FIG.14B). For instance, in FIGS. 14A and 14B, the first interactive element104 supported by the first part 101 may urge the second interactiveelement 106 to the second position upon operatively engaging the firstpart 101 and the second part 102.

In some embodiments, a spring, finger, or bias member may be arranged orotherwise provided between the interactive elements for allowing theinteractive elements to interact with each other via the bias member,for example, upon the first part 101 and the second part 102 beingoperatively engaged. In further embodiments, the bias member mayfunction as a conductor (e.g., an electrically conductive medium,magnetically conductive medium, thermally conductive medium, and/or thelike), such as a metal and/or the like, between the interactiveelements. For example, in embodiments where the bias remember is anelectrically conductive medium, the bias member may be arranged and/orconfigured for allowing an electrical connection between the interactiveelements via the bias member.

Alternatively or in addition, in some embodiments, one or more of theinteractive elements may be supported by a spring, finger, or other biasmember for contacting the other interactive element upon the first part101 and the second part 102 being operatively engaged. Thus in suchembodiments, the supported interactive element(s) may be biased in afirst direction (e.g., FIG. 14A) and/or urgeable or otherwise moveableto a second position (e.g., FIG. 14B) as previously described.

In various embodiments, such as the embodiments exemplified in FIGS. 15Aand 15B, more than one interactive element (e.g., first interactiveelement 104, first interactive element 104′, second interactive element106, second interactive element 106′, and/or the like) may be spacedapart from each other on one of the first part 101 and the second part102. At least one of the more than one interactive element (e.g., secondinteractive element 106) or a portion thereof may be movable by aportion (e.g., interactive element 104, a finger, pusher, and/or thelike) of the other of the first part 101 and the second part 102 uponthe first part 101 and the second part 102 being operatively engaged.

Thus, for example, as shown in FIGS. 15A and 15B, upon the first part101 and the second part 102 being operatively engaged, the secondinteractive element 106′ may be urged by the first interactive element104 toward the second interactive element 106. Accordingly, the secondinteractive element 106′ may be moved to contact or otherwise placedwithin range with the second interactive element 106 to allow some orall of the interactive elements (e.g., first interactive element 104,second interactive element 106′, and/or second interactive element 106)to interact with each other. Likewise, in other embodiments, the firstinteractive element 104′ (not shown) may be moved to contact orotherwise placed within range with the first interactive element 104 ina similar manner to allow the interactive elements (e.g., firstinteractive element 104, first interactive element 104′, secondinteractive element 106, and/or the like) to interact with each other.

In some embodiments, for example, the first interactive element 104 andthe second interactive element 106 can be arranged on one of the firstpart 101 and the second part 102 to be spaced apart and movable relativeto each other in a manner such as that previously described. In suchembodiments, for instance, a portion of the other of the first part 101and the second part, such as a tab, finger, and/or the like may bearranged to urge the first interactive element 104 and the secondinteractive element 106 toward each other to allow the interactiveelements to interact (e.g., contact) with each other. Thus in suchembodiments, most or all of the interactive elements may be provided onone of the housing portions, for example the durable housing portion 30(FIGS. 1-6C), which may allow for reuse of the interactive elements. Inother embodiments, the movable interactive element may be any suitableintermediary member (e.g., second interactive element 106′ in FIGS. 15Aand 15B) configured to be movable relative to one or more of theinteractive elements in a manner described, for example, with respect toFIGS. 15A and 15B.

In other embodiments (see, e.g., FIG. 31 described later), the movableinteractive element (or a portion thereof) may instead be a flexiblelayer, such as a film made of a suitably flexible material including,but not limited to, a Mylar and/or the like, that can be pushed upon bythe portion of the opposing part to contact the other interactiveelement. In further embodiments, the flexible layer may be a conductivelayer, such an electrically conductive medium (e.g., metal and/or thelike), magnetically conductive medium (e.g., a ferrous conduit),thermally conductive medium, and/or the like.

Thus in various embodiments, as part of a process of assembling a firstpart 101 and a second part 102 of a medical device system 100, a usermay bring the first part 101 and the second part 102 together tooperatively engage each other or otherwise be in sufficiently closeproximity. Accordingly, a first interactive element 104 and a secondinteractive element 106 may be interactable with each other todetermine, for example, whether the first part 101 and the second part102 have been properly aligned and/or connected.

In various embodiments, the interactive elements (e.g., firstinteractive element 104, second interactive element 106, and/or thelike) may allow for, but is not limited to, tracking a number of times acomponent has been connected to and/or disconnected from othercomponents, verifying proper connection and/or alignment of componentsin a medication delivery system prior to each delivery step, checking,sensing, and/or measuring parameters, such as ambient parameters (e.g.,ambient magnetic fields), operating parameters, and/or the like,alerting users to conditions, such as conditions outside operatingparameters of the delivery system, and/or the like.

Various embodiments may employ different arrangements of interactiveelements on the first part 101 and/or the second part 102. For instance,in embodiments in which one of the first part 101 and the second part102 is intended to be disposable (e.g., disposed of after one or aprescribed number of uses or period of use), some of the interactiveelements may be provided on the disposable part, while other interactiveelements may be provided on a durable part (i.e., not intended to bedisposed). As a result, after a period of usage, the interactiveelement(s) on the disposable part that may have attracted and collectedstray material can be disposed of with the disposable part.

On the other hand, the interactive element(s) on the durable part can besufficiently clean and free (or be cleaned) of stray material forfurther usage. In such embodiments, arranging at least some of theinteractive element(s) on the durable portion may provide certainadvantages, such as, but not limited to, being more cost-effective, forexample, by arranging interactive elements on respective parts based oncost; easier to manufacture and/or install, and/or the like. Forexample, electronics and circuitry, such as, but not limited to, asensor (e.g., FIGS. 16-23), a responsive device (e.g., FIGS. 24-29B and48), and/or other circuitry or electronics, may be arranged on thedurable part.

In yet other embodiments, arranging at least some of the interactiveelement(s) on the disposable portion may provide certain advantages,such as, but not limited to, maintenance, cost, and/or the like. Forexample, such embodiments may allow for the interactive element(s) thathave worn down, been contaminated, or otherwise collected stray materialto be disposed of with the disposable part.

FIGS. 16-19 illustrate a medical device system 200 according to variousembodiments of the present invention. The medical device system 200 mayinclude features similar to or employed as an embodiment of the medicaldevice system 100 (e.g., FIGS. 7-15B) and/or the other medical devicesystems discussed in the disclosure. Although the medical device system200 may include features similar or used with the embodiments of FIGS.7-15B, it should be understood that the medical device system 200 mayalso include some or all of the same features and operate in a mannersimilar to that shown and described in the embodiments of FIGS. 1-6C and20-32B. In addition, some or all of the features shown in FIGS. 1-15Band 20-32B may be combined in various ways and included in theembodiments shown in FIGS. 16-19. Likewise, it should be understood thatany of the features of the embodiments of FIGS. 16-19 may be combined orotherwise incorporated into any of the other embodiments of FIGS. 16-19as well as any other embodiment herein discussed.

In some embodiments, such as the embodiment exemplified in FIG. 16, atleast one of a first interactive element 204, which may be similar tofirst interactive element 104 (e.g., FIGS. 7-15B), and a secondinteractive element 206, which may be similar to the second interactiveelement 106 (e.g., FIGS. 7-15B), may be a suitable sensor 205 forsensing the other of the first interactive element 204 and the secondinteractive element 206 and/or an interactive element, such as aconductive medium (e.g., FIG. 18 discussed later) operatively connectedto or otherwise associated with the other of the first interactiveelement 204 and the second interactive element 206. Accordingly, uponthe sensor 205 detecting the presence of the other of the firstinteractive element 204 and the second interactive element 206, thealignment system 200 may determine whether the first part 201 and secondpart 202 have been properly connected (i.e., aligned and connected).

In various embodiments, suitable electronics may be connected to thesensor 205 and/or the other of the first interactive element 204 and thesecond interactive element 206 to provide a controlled power signal toselectively activate or otherwise control the sensor 205 and/or theother of the first interactive element 204 and the second interactiveelement 206. For example, the sensor 205 may be controlled to activateupon a manual activation of a control button, switch, or other manualoperator on one of the connectable components or on a remote-controllerdevice (not shown) connected in wireless communication with the sensor205 through suitable control electronics. As another example, the sensor205 may be controlled to activate automatically after a certain action,such as activation of a button, and/or the like or after a certainamount of time. In some embodiments, the sensor 205 may be controlled toactivate upon activation or insertion of a particular component ordevice, such as, but not limited to, a needle inserter to insert aneedle or cannula.

Examples of various needle insertion tools are described in, but are notlimited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; U.S. patent application Ser. No. 11/645,435, filedDec. 26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method,” all of which are herein incorporated byreference in their entirety. Thus, in such examples, the sensor 205 maybe activated, for example, before or after, the first part 201 and thesecond part 202 are brought operatively engaged.

In some embodiments, the sensor 205 may be activated upon interactingwith the other of the first interactive element 204 and the secondinteractive element 206. In some embodiments, an activating element,such as an activating magnet and/or the like, may be provided on atleast one of the first part 201 and the second part 202. The activatingelement may activate the sensor 205 upon interacting with each other,for example by contacting each other when the first part 201 and thesecond part 202 are operatively engaged and properly aligned. Inparticular embodiments, the activating element may be one of theinteractive elements.

The sensor 205 may be any suitable detector configured to detect adetectable feature, such as an interactive element (e.g., firstinteractive element 204, second interactive element 206, and/or thelike) or a presence of an interactive element, such as a magnetic field,electric field, and/or the like provided by the interactive element. Infurther embodiments, the sensor 205 may be configured to and/orassociated with electronics configured to produce an electronicallydetectable state or signal upon detecting the detectable feature. Forexample, the sensor 205 may be a sensor pad and/or the like configuredto sense, detect, and/or otherwise interact with an interactive elementupon the interactive element being in sufficient proximity (e.g., incontact) with the sensor pad. In certain embodiments, the sensor 205 mayinclude a conventional activating switch or a conventional devicecapable of detecting a particular detectable feature such as aninteractive element (e.g., first interactive element 204, secondinteractive element 206, and/or the like) or a presence of aninteractive element, such as a magnetic field, electric field, and/orthe like provided by the interactive element.

In some embodiments, the sensor 205 may be configured to sense, detect,or measure a presence of the interactive element. For example, suchembodiments may allow for the sensor 205 to sense a presence (e.g., amagnetic field) of the interactive element rather than the elementitself. In particular, the sensor 205 may be configured to sense,detect, or measure, but is not limited to, magnetic fields; electricfields; temperature or heat; optical and/or visual features (e.g.,barcodes, colors, grayscale, and/or the like); tactile features; audiofeatures; radio frequencies (RF) or other radio signals; ultravioletlight, or other light; force; torque; resistances (e.g., codedresistance pattern); capacitances; inductances; ultrasonic signals,and/or the like; and/or the like provided by, emitted from, produced by,or otherwise present in an interactive element (e.g., the secondinteractive element 206).

For example, the sensor 205 may be configured to sense a magnetic fieldemitted by a magnetic second interactive element 206 in a case where thefirst part 201 and the second part 202 are connected and the sensor 205and the second interactive element 206 are in proper alignment. If thefirst part 201 and the second part 202 are operatively engaged and thesensor 205 fails to detect the magnetic field provided by the magneticsecond interactive element 206, then this may indicate that the firstpart 201 and the second part 202 are not properly aligned. On thecontrary, if the first part 201 and the second part 202 are operativelyengaged and the sensor 205 detects the magnetic field provided by themagnetic second interactive element 206, then this may indicate that thefirst part 201 and the second part 202 are properly aligned (i.e., thefirst part 201 and the second part 202 are within a certain tolerance ofalignment relative to each other).

In further embodiments, the sensor 205 may be configured to measure avalue or presence parameter, magnitudes, changes, gradients, polarities,vectors, field directions, and/or any other measurable parametersuitable for detecting and/or measuring a detectable feature. Forexample, a sensor 205 may be configured to measure a gauss level of amagnetic field provided by a second interactive element 206.

In various embodiments, the detectable feature (e.g., second interactiveelement 206) may be selected, configured, and/or arranged to provide aparticular detectability (i.e., a characteristic or trait capable ofbeing detected) such that, for example, the interactive element and/orthe presence of the interactive element may be sensed by the sensor 205only when the first part 201 and the second part 202 are properlyaligned. For instance, a magnetic second interactive element 206 may beselected to provide a magnetic field having a particular gauss levelthat may be detectable by the sensor 205 only if sufficiently proximateto the magnetic second interactive element (i.e., the first part 201 andthe second part 202 are within a certain tolerance of alignment relativeto each other).

Alternatively or in addition, the sensor 205 may be selected,configured, and/or arranged to select a sensitivity of the sensor orotherwise control an amount sensed of the detectable feature by thesensor 205. Thus, for example, the interactive element and/or thepresence of the interactive element may be sensed by the sensor 205 onlywhen the first part 201 and the second part 202 are properly aligned;otherwise, the detectable feature would not be sufficiently proximate tobe detectable by the sensor 205 having a reduced sensitivity. Forinstance, a sensor 205 may be configured to sense, for example, amagnetic second interactive element 206 or a field of the magneticsecond interactive element 206 only if sufficiently proximate to themagnetic second interactive element 206.

Such embodiments may allow, for example, for a lesser tolerance inconnecting the first part 201 and the second part 202. Accordingly, suchembodiments may be used in a case where a connection between the firstpart 201 and the second part 202 need (but not limited to) moreprecision. In other embodiments, the sensor may have an increasedsensitivity or the like. Such embodiments may allow, for example, for agreater tolerance in connecting the first part and second part.

In some embodiments, the sensor 205 or other associated circuitry may beconfigured such that a detection not meeting a certain range (e.g.,below the range or above the range) or threshold may be ignored orotherwise determined to be unacceptable by the sensor 205 (or otherassociated circuitry). Thus, in such embodiments, a case where thesensor 205 does not detect the interactive element and/or the presenceof the interactive element, the sensor 205 (or other circuitry) mayprovide an indication that the first part 201 and the second part 202have not been properly engaged (e.g., connected and/or aligned).

In yet further embodiments, the sensor 205 and/or other associatedelectronics may be configured such that a detection not meeting acertain range or threshold (i.e., determined to be unacceptable) mayprovide an indication that the detection does not meet the certain rangeor threshold. For example, such an indication may indicate that thefirst part 201 and the second part 202 are operatively engaged, but notproperly aligned. In further embodiments, the indicator may indicate,for example, that the parts are laterally misaligned in one or moredirections, the parts are have not been brought sufficiently together,and/or the parts have not been connected properly (e.g., connectedbackwards).

In some embodiments, other interactive elements or structures may beprovided to regulate the sensing and/or measuring ability of the sensor205 and/or the detectability and/or measurability of the detectablefeature. For example, a heat-emitting second interactive element 206 maybe at least partially surrounded by a low thermally conductive material,such as plastic, rubber, wood, and/or the like. This may allow aheat-sensing sensor 205 to sense the heat-emitting second interactiveelement 206 and/or a suitable presence thereof only when the first part201 and the second part 202 are properly aligned, thus substantiallypreventing a false detection of heat that may be emitted, for example,laterally from the heat-emitting second interactive element 206.

In various embodiments, one of the interactive elements may have acapacitance that is measurable. Another interactive element (or othercomponent) may be configured to affect the capacitance of the one of theinteractive elements, for example, by being brought in proximity orcontact with the one of the interactive elements. The affectedcapacitance of the one of the interactive elements may be measured orotherwise, for example, by a sensor (e.g., sensor 205) detected toindicate a change in state (e.g., that two components have beenconnected).

In various embodiments, one of the interactive elements may have aninductance that is measurable. Another interactive element (or othercomponent) may be configured to affect the inductance of the one of theinteractive elements, for example, by being brought in proximity orcontact with the one of the interactive elements. The affectedinductance of the one of the interactive elements may be measured orotherwise, for example, by a sensor (e.g., sensor 205) detected toindicate a change in state (e.g., that two components have beenconnected).

In some embodiments having multiple pairs of interactive elements, thefirst interactive element 204 and the first interactive element 204′ maybe sensor 205 and sensor 205′ respectively that may be configured todetect, for example, the second interactive element 206 and the secondinteractive element 206′ respectively. Thus, the system 200 may bedeemed to have been properly connected in case where the sensor 205detects the second interactive element 206 and the sensor 205′ detectsthe second interactive element 206′. In other embodiments, the secondinteractive element 206 and the second interactive element 206′ may besensor 205 and sensor 205′ respectively that may be configured todetect, for example, the first interactive element 204 and the firstinteractive element 204′ respectively. In some embodiments, such as theembodiment exemplified in FIG. 17, at least one of the first interactiveelement 204 and the first interactive element 204′ may be a sensor 205configured to detect one of the second interactive element 206 and thesecond interactive element 206′ and the other of the second interactiveelement 206 and the second interactive element 206′ may be a sensor 205′configured to detect the other of the first interactive element 204 andthe first interactive element 204′.

In some embodiments, both the first interactive element 204 and thesecond interactive element 206 may each be sensors 205. In suchembodiments, one or more of the sensors 205 may be configured to detectthe other sensor 205 and/or other interactive element(s). For example,the first part 201 and the second part 202 may be deemed to have beenoperatively engaged properly in a case where (but not limited to) one ofthe sensors 205 detects the other sensor 205, the sensors 205 bothdetect each other, one or more of the sensors 205 detects an otherinteractive element, and/or the like.

In further embodiments, further sensors may be provided for detectingother sensors (and/or interactive elements). In such embodiments, thefirst part 201 and the second part 202 may be deemed to have beenoperatively engaged properly, but is not limited to, upon one or more ora predetermined amount of the sensors 205 detecting a particular or anyof the other sensors 205, the sensors 205 detecting each other, one ormore of the sensors 205 detecting an other interactive element, and/orthe like.

In various embodiments, one or more additional sensing structures, suchas those described above, may be provided to align the first part 201and the second part 202, for example, to increase reliability ofalignment and/or decrease time for sensing proper alignment.

Thus in various embodiments, as part of a process of assembling a firstpart 201 and a second part 202 of a medical device system 200, a usermay bring the first part 201 and the second part 202 together tooperatively engage each other or otherwise be in sufficiently closeproximity. Accordingly, a sensor 205 may detect a detectable feature todetermine, for example, whether the first part 201 and the second part202 have been operatively engaged properly (e.g., aligned and/orconnected).

In some embodiments, such as the embodiment exemplified in FIG. 18, aconductive medium 208 may be at a position adjacent one of theinteractive element(s) (e.g., the second interactive element 206 in FIG.18) or otherwise in communication with the interactive element to allowthe conductive medium 208 to function as a conductor for the interactiveelement. In such embodiments, the interactive element may interact withthe conductive medium 208 to allow the conductive medium 208 to be havesimilar characteristics or properties, though not necessarily exactlythe same characteristics or properties. For example, a magnetic secondinteractive element 206 may provide a magnetic charge to a magneticconductive medium 208. The conductive medium 208 may be made of amaterial, such as, but not limited to, an electrically conductivematerial (e.g., metal, graphite, salt solutions, plasma, and/or thelike), a magnetically attractive material (e.g., metal), a sufficientlyhigh thermally conductive material (e.g., metal, or any other materialwith a thermal conductivity, for example (but not limited to), above 1),and/or the like.

In further embodiments, the conductive medium 208 may be arranged on itsrespective part to allow the interactive element to be interactable withthe other interactive element (e.g., the sensor 205 in FIG. 18) on theopposing part via the conductive medium 208 in any of the mannersdescribed in the disclosure. For example, in particular embodiments, thesensor 205 may detect or otherwise interact with the conductive medium208 in a case where the first part 201 and the second part 202 areoperatively engaged properly. Accordingly, the second interactiveelement 206 or presence thereof may be detectable by the sensor 205 viathe conductive medium 208. Thus, some embodiments may allow for thesensor 205 to detect the conductive medium 208 in addition to oralternative to the interactive element (e.g., the second interactiveelement 206). For example, a magnetic second interactive element maymagnetize a magnetically attractive conductive medium 208, which maythen be detected by the sensor 205.

In some embodiments, such as the embodiment exemplified in FIG. 19, theconductive medium 208 may be arranged at a position adjacent the otherinteractive element (e.g., the sensor 205 in FIG. 19) or otherwise incommunication with the other interactive element to allow the conductivemedium 208 to function as a conductor for the other interactive element.In further embodiments, the conductive medium 208 may be arranged on itsrespective part to allow the other interactive element to beinteractable with the interactive element (e.g., the first interactiveelement 204 in FIG. 19) on the opposing part via the conductive medium208 in any of the manners described in the disclosure.

For example, in particular embodiments, the first interactive element204 may interact with the conductive medium 208 in a case where thefirst part 201 and the second part 202 are operatively engaged properly.Accordingly, the first interactive element 204 may be detectable by thesensor 205 via the conductive medium 208. Thus, some embodiments mayallow for the sensor 205 to detect the interactive element (e.g., thesecond interactive element 206) through the conductive medium 208 inaddition to or alternative directly detecting the interactive element.For example, an electrical connection between the first interactiveelement 204 and the conductive medium 208 (e.g., electrically conductivemedium) may be established by contacting the conductive medium 208,which may then be detected by the sensor 205.

Thus in various embodiments, as part of a process of assembling a firstpart 201 and a second part 202 of a medical device system 200, a usermay bring the first part 201 and the second part 202 together tooperatively engage each other or otherwise be in sufficiently closeproximity. Accordingly, an interactive element (e.g., first interactiveelement 204, second interactive element 206, and/or the like), a sensor205, and/or an conductive material 208 may interactable with each otherto determine, for example, whether the first part 201 and the secondpart 202 have been operatively engaged properly aligned (e.g., connectedand/or aligned).

In various embodiments, the interactive element(s) (e.g., firstinteractive element 204, second interactive element 206, and/or thelike), the sensor(s) 205, and/or the conductive medium 208 need not beused or otherwise limited to two housing portions. FIGS. 20-23illustrate a medical device system 300 according to various embodimentsof the present invention. The medical device system 300 may includefeatures similar or employed as an embodiment of the medical devicesystem 100 (e.g., FIGS. 7-15B), the medical device system 200 (e.g.,FIGS. 16-19) and/or other delivery devices discussed in the disclosure.Although the medical device system 300 may include features similar orused with the embodiments of FIGS. 7-19, it should be understood thatthe medical device system 300 may also include some or all of the samefeatures and operate in a manner similar to that shown and described inthe embodiments of FIGS. 1-6C and 24-32B. In addition, some or all ofthe features shown in FIGS. 1-19 and 24-32B may be combined in variousways and included in the embodiments shown in FIGS. 20-23. Likewise, itshould be understood that any of the features of the embodiments ofFIGS. 20-23 may be combined or otherwise incorporated into any of theother embodiments of FIGS. 20-23 as well as any other embodiment hereindiscussed.

As previously described, a first part 301, which may be similar to thefirst part 101 (and 201) (e.g., FIGS. 7-19), and a second part 302,which may be similar to the second part 102 (and 202) (e.g., FIGS.7-19), may be two housing portions, such as, but not limited to, adurable housing portion 30 (e.g., FIGS. 1-6C) and a disposable housingportion 20 (e.g., FIGS. 1-6C), as previously described. A third part 303may be provided that may be, but is not limited to, a base portion 21(e.g., FIGS. 1-6C). In some embodiments, the conductive medium 308 orfurther conductive mediums (e.g., electrically conductive medium,magnetically attractive material, such as a yoke, ferrous conduit,thermally conductive material, and/or the like) may be provided on atleast one of the parts. This may allow for a connection or interactionbetween the interactive element(s) (e.g., first interactive element 304,second interactive element 306, and/or the like) and/or the sensor(s)305.

For example, in the embodiment exemplified in FIG. 20, a conductivemedium 308 (e.g., electrically conductive medium, yoke, ferrous conduit,and/or the like) may be provided in a third part 303. A firstinteractive element 304 may supported by a first part 301 in a positionto interact with the conductive medium 308 of the third part 303 uponthe first part 301 being operatively engaged with the third part 303. Asensor 305 may be supported by a second part 302 in a position tointeract with the conductive medium 308 of the third part 303 upon thesecond part 302 being operatively engaged with the third part 303.

Thus in some embodiments, in a case where a first part 301 isoperatively engaged with a third part 303 and a second part 302 isoperatively engaged with the third part 303, a first interactive element304 may be detectable by a sensor 305 via a conductive medium 308. Invarious embodiments, the arrangement of each of the conductive medium308, the first interactive element 304 (or other interactive elements,such as second interactive element 306, and/or the like), and the sensor305 need not be limited to the third part 303, the first part 301, andthe second part 302, respectively, but may be arranged on any of thecomponents as well as any other components as needed.

Another example as exemplified in FIG. 21, a conductive medium 308′(e.g., electrically conductive medium, yoke, ferrous conduit, and/or thelike) may be provided in a third part 303 as well as a first part 301. Afirst interactive element 304 may supported by a second part 302 in aposition to interact with the conductive medium 308′ of the third part303 upon the second part 302 being operatively engaged with the thirdpart 303. A sensor 305 may be supported by the second part 302 in aposition to interact with a conductive medium 308 of the first part 301in a case where each of the first part 301 and the second part 302 isoperatively engaged with the third part 303.

Thus in some embodiments, in a case where a first part 301 isoperatively engaged with a third part 303 and a second part 302 isoperatively engaged with the third part 303, a first interactive element304 may be detectable by a sensor 305 via a conductive medium 308 and aconductive medium 308′. In various embodiments, the arrangement of eachof the conductive medium 308 and 308′, the first interactive element 304(or other interactive elements (e.g., second interactive element 306,and/or the like), and the sensor 305 need not be limited to theexemplified arrangements, but may be arranged on any of the componentsas well as any other components as needed.

In some embodiments, such as the embodiment exemplified in FIG. 22, morethan one sensor, such as a sensor 305 and a sensor 305′, may be arrangedon one of the parts (e.g., first part 301, and/or the like). Each of thesensor 305 and the sensor 305′ may be configured to sense a respectiveinteractive element (e.g., first interactive element 304, secondinteractive element 306, and/or the like) located on each of theremaining parts (e.g., second part 302, third part 303, and/or thelike). Thus in some embodiments, in a case where each of a first part301 and a second part 302 is operatively engaged with a third part 303,a first interactive element 304 of the third part 303 may be detectableby a sensor 305 (i.e., a first sensor). Similarly, a second interactiveelement 306 of the second part 302 may be detectable by a sensor 305′(i.e., a second sensor).

In other embodiments, such as the embodiment exemplified in FIG. 23, asensor 305 may be arranged on one of the parts (e.g., the second part302, and/or the like) and configured to sense interactive elements(e.g., first interactive element 304, first interactive element 304′,second interactive element 306, second interactive element 306′, and/orthe like), and/or the like arranged on each of the remaining parts(e.g., first part 301, third part 303, and/or the like). Thus in someembodiments, in a case where each of a first part 301 and a second part302 is operatively engaged with a third part 303, a first interactiveelement 304 of the third part 303 and a first interactive element 304′of the second part 302 may be detectable by the sensor 305.

With reference to FIGS. 20-23, in various embodiments, arrangement ofeach of the interactive element(s) (e.g., first interactive element 304(and/or 304′), second interactive element 306 (and/or 306′), and/or thelike), sensor(s) 305 (and/or 305′), and/or conductive medium(s) 308(and/or 308′) need not be limited to the exemplified arrangements. Thevarious interactive element(s), sensor(s), and/or conductive medium(s)may be arranged as needed in any suitable configuration amongst some orall of the components (e.g., first part 301, second part 302, third part303) as well as any other components (e.g., further parts, such as anneedle-inserting device as discussed further below, electronics housing,and/or the like). As a non-limiting example, in FIG. 22, the sensor 305and the sensor 305′ may be arranged on the second part 302, and/or thethird part 303, or further part. As another non-limiting example, inFIG. 21, the first interactive element 304 and the sensor 305 may bearranged on the first part 301 and the conductive medium 308 may bearranged on the second part 302 (or any other part) to allow the firstinteractive element 304 to interact with the sensor 305 through theconductive medium 308 and the conductive medium 308′.

With reference to FIGS. 20-23, in some embodiments, each of theinteractive element(s) (e.g., first interactive element 304 (and/or304′), second interactive element 306 (and/or 306′), and/or the like),sensor(s) 305 (and/or 305′), and/or conductive medium(s) 308 (and/or308′) may be configured and/or arranged on their respective parts suchthat the components can interact with each other only if the first part301, the second part 302, and/or the third part 303 (and/or any furtherpart) are operatively engaged properly. For example, in FIG. 21, ifwhile the parts are operatively engaged, the first part 301 is not movedclose enough to the second part 302, the conductive medium 308 of thefirst part 301 may not provide a connection between the firstinteractive element 304, the conductive medium 308′ of the third part303, and the sensor 305. Thus, in such an example, the first part 301,the second part 302, and the third part 303 have not been operativelyengaged properly.

Thus various embodiments may allow for verification between three (ortwo or more than three) distinct and separate components, verificationof correct positioning between three distinct and separate components,verification that three distinct and separate components have beenconnected in the correct order, a safety mechanism to providenotification of separation (intentional or accidental) of any individualcomponent in a multi-component system, and/or the like.

Although the medical device system 300 may be similar or used with theembodiments of FIGS. 7-19, it should be understood that the medicaldevice system 200 may also include some or all of the same componentsand operate in a manner similar to that shown and described in theembodiments relating to the medical device system 300. In addition, someor all of the features shown in FIGS. 20-23 may be combined in variousways and included in the embodiment shown in FIGS. 7-19. For instance,although the description relating to FIGS. 20-23 applied to embodimentshaving three (or more) housing portions, the features relating to theembodiments of FIGS. 20-23 may be used in addition with or in place ofthose embodiments having two housing portion discussed, for example,with respect to FIGS. 7-19.

FIGS. 24-29B and 48 illustrate a medical device system 400 according tovarious embodiments of the present invention. The medical device system400 may include features similar or employed as an embodiment of themedical device system 100 (e.g., FIGS. 7-23), the medical device system200 (e.g., FIGS. 16-19), the medical device system 300 (e.g., FIGS.20-23), and/or other medical device system discussed in the disclosure.Although the medical device system 400 may include features similar orused with the embodiments of FIGS. 7-23, it should be understood thatthe medical device system 400 may also include some or all of the samefeatures and operate in a manner similar to that shown and described inthe embodiments of FIGS. 1-6C and 30A-32B. In addition, some or all ofthe features shown in FIGS. 1-23 and 30A-32B may be combined in variousways and included in the embodiments shown in FIGS. 24-29B and 48.Likewise, it should be understood that any of the features of theembodiments of FIGS. 24-29B and 48 may be combined or otherwiseincorporated into any of the other embodiments of FIGS. 24-29B and 48 aswell as any other embodiment herein discussed.

The medical device system 400 may include a responsive device 410configured to provide an electronically detectable state or signal inresponse to an interaction (or lack thereof) between two or moreinteractive elements. As previously discussed, an interaction betweentwo or more interactive elements may occur in a case where the firstpart 401 and the second part 402 are operatively engaged properly orotherwise brought into a pre-defined, sufficiently aligned positionand/or in a pre-defined, sufficiently close proximity. The predefinedaligned position and/or proximity, for example, may correspond to aproperly aligned and mutually proximate position for connection of thefirst part 401 and the second part 402 for operation. Thus, in someembodiments, the responsive device 410 may be configured to provide asignal in a case where the first part 401 and the second part 402 areoperatively engaged (or otherwise in sufficient proximity) and properlyaligned. The signal may indicate, for example, the two or moreinteractive elements have interacted, and thus the first part 401 andthe second part 402 have been operatively engaged properly. In someembodiments, the responsive device 410 may be configured to changebetween a relatively non-detectable state to a detectable state (e.g.,electrically detectable state) in response to an interaction between twoor more interactive elements.

In some embodiments, the responsive device 410 may be configured todetect the interaction between the two or more interactive elements. Infurther embodiments, the responsive device 410 may be configured toproduce an electronically detectable state or signal in response to theresponsive device 410 detecting an interaction between the two or moreinteractive elements. In other embodiments, a sensor, such as the sensor205 (or 305) (e.g., FIGS. 16-23) or other electronics may be configuredto detect the interaction between the two or more interactive elementsor to detect a detectable feature as previously described. In furtherembodiments, the responsive device 410 may be configured to produce anelectronically detectable state or signal in response to the sensordetecting an interaction between the two or more interactive elements.

In some embodiments, such as the embodiment shown in FIG. 24, theresponsive device 410, may be configured to provide an electronicallydetectable state or signal in response to an interaction between twointeractive elements, such as a first interactive element 404, which maybe similar to the first interactive element 104 (204, and/or 304) (e.g.,FIGS. 7-23), and a second interactive element 406, which may be similarto the second interactive element 106 (206, and/or 306) (e.g., FIGS.7-23). For example, the responsive device 410 may be configured todetect an electrical connection (or lack thereof) between the firstinteractive element 404, which may be an electrically conductivematerial, on the first part 401 and a second interactive element, suchas an electrical contact, on the second part 402.

In some embodiments, such as the embodiment shown in FIG. 25, theresponsive device 410, may be configured to provide an electronicallydetectable state or signal in response to an interaction (or lackthereof) between an interactive element or detectable feature (e.g.,first interactive element 404) and a sensor 405, for example asdescribed in FIGS. 16-23.

In some embodiments, such as the embodiment shown in FIG. 26, theresponsive device 410, may be configured to provide an electronicallydetectable state or signal in response to an interaction between theresponsive device 410 and an interactive element 412, which may besimilar to the first interactive element 404 (e.g., FIG. 23) and/or thesecond interactive element 406 (e.g., FIG. 23). In further embodiments,the responsive device 410 may be an activating switch or the likeconfigured and/or arranged to be activated upon interacting with theinteractive element 412. For example, the responsive device 410 may besupported by one or both of the first part 401 and the second part 402in a position to be activated by the interactive element 412, when thefirst part 401 and the second part 402 are brought into a pre-defined,sufficiently aligned position and/or in a pre-defined, sufficientlyclose proximity. The predefined aligned position and/or proximity, forexample, may correspond to a properly aligned and mutually proximateposition for connection of the first part 401 and the second part 402for operation.

The interactive element 412 may activate the responsive device 410, forexample, by contacting the responsive device 410 and/or a partassociated with the responsive device 410, such as an electricallyconductive material 408 adjacent the responsive device 410 (e.g., FIG.28). Accordingly, in such embodiments, in a case where the first part401 and the second part 402 are brought together and the responsivedevice 410 is activated by the interactive element 412, the responsivedevice 410 may provide a signal and/or the like indicating that thefirst part 401 and the second part 402 have been operatively engagedproperly. In other embodiments, a similar responsive device 410 may beprovided on the first part 401 and an associated interactive element 412for activating the responsive device 410 may be provided on the secondpart 402, either in addition to or as an alternative to the arrangementshown in FIG. 26.

In some embodiments, such as the embodiment exemplified in FIG. 27,multiple responsive devices 410 and 410′ and interactive elements 412and 412′ may be provided on the first part 401 and the second part 402respectively. The interactive element 412′, for example, may be similarto or one or more of the first interactive element 104 (204, or 304),the first interactive element 104′ (204′, or 304′), the secondinteractive element 106 (206, or 306), the second interactive element106′ (206′, or 306′), and/or the like previously described with respectto FIGS. 7-23. Returning to FIG. 27, in other embodiments, multipleresponsive devices 410 may be provided with at least one responsivedevice 410 on each of the first part 401 and the second part 402 forinteracting with a respective interactive element 412 on the opposingpart. The embodiments described need not be limited to multipleresponsive devices 410 and 410′ and interactive elements 412 and 412′.Various embodiments may include multiple first interactive elements 404,404′ and second interactive elements 406, 406′, as described, forexample, with respect to FIG. 24 in addition to or in alternative to theinteractive elements 412 and 412′ of FIG. 27. Some embodiments mayinclude multiple first interactive elements 404, 404′ and sensors 405,405′, as described, for example, with respect to FIG. 25 in addition toor in alternative to the interactive elements 412 and 412 of FIG. 27.

In some embodiments, such as the embodiment exemplified in FIG. 28, aninteractive element 412 on the first part 401 (and/or the second part402) may be arranged to function with a conductive medium 408 on thesecond part 402 (and/or the first part 401), for example, as previouslydescribed with respect to FIGS. 9 and 18-23. With reference to FIG. 28,a responsive device 410 may be located at a position adjacent theconductive medium 408 or otherwise in communication with the conductivemedium 408 to allow the conductive medium 408 to function as a conductorfor the responsive device 410. The responsive device 410 may be remotefrom the location of the interactive element 412 on the first part 401.In such embodiments, the interactive element 412 may interact with theconductive medium 408 and thus, interact with the responsive device 410through the conductive medium 408, for example, to activate theresponsive device 410. For example, this may occur in a case where thefirst part 401 and the second part 402 are brought together foroperative engagement and the conductive medium 408 and the interactiveelement 412 contact each other or otherwise interact with each other.

In some embodiments, a conductive medium 408 may be arranged adjacent toor otherwise in communication with the interactive element 412 to allowthe conductive medium 408 to function as a conductor for the interactiveelement 412, for example, as previously described with respect to FIGS.9 and 18-23. Returning to FIG. 28, in such embodiments, the interactiveelement 412 may interact with the conductive medium 408, which may bethen interacted with the responsive device 410, for example upon thefirst part 401 and the second part 402 being operatively engaged. Forexample, in a case where the interactive element 412 is an electricalcontact and the conductive medium 408 is an electrically conductivemedium (e.g., copper, aluminum, graphite, and/or the like), theinteractive element 412 may energize the conductive medium 408. Thus, anelectrical connection may be formed between the interactive element 412and the responsive device 410 via the conductive medium 408, forexample, to activate the responsive device 410 in a case where the firstpart 401 and the second part 402 are operatively engaged properly.

With reference to FIGS. 24-28, the responsive device 410 may beconnected in electrical communication with control electronics 414. Thecontrol electronics 414 may be incorporated within the controlelectronics for controlling a drive device 44 (e.g., FIG. 4) such as,but not limited to, the control electronics 52 (e.g., FIG. 4) forcontrolling the drive device 44. Alternatively, the control electronics414 may be separate from and in addition to the control electronics 52,but connected in electrical communication with the control electronics52 and/or the drive device 44 to provide a drive control signal to thedrive device 44. More specifically, the control electronics 414 may beconfigured to inhibit operation of the drive device 44, unless theresponsive device 410 provides a signal or a change in state to thecontrol electronics 414. For instance, as previously discussed, theresponsive device 410 may provide such a signal or a change in stateupon being activated by the interactive element 412, for example, in acase where the first part 401 and the second part 402 are in properalignment and sufficiently close in proximity to connect for operation.In other words, the drive device 44 may be inoperable unless the firstpart 401 and the second part 402 are operatively engaged properly (i.e.,aligned and/or connected properly).

In other embodiments, the sensor 205 (305, 405) (e.g., FIGS. 16-28) orelectronics associated with the sensor 205 may be connected inelectrical communication with control electronics 414 in addition to orin place of the responsive device 410. The control electronics 414 maybe configured to inhibit operation of the drive device 44, unless thesensor 205 or electronics associated with the sensor 205 may provides asignal or a change in state to the control electronics 414. For example,as previously discussed, the sensor 205 or electronics associated withthe sensor 205 may provide such a signal or a change in state upondetecting an interactive element, for example, in a case where the firstpart 401 and the second part 402 are in proper alignment andsufficiently close in proximity to connect for operation. In otherwords, the drive device 44 may be inoperable unless the first part 401and the second part 402 are operatively engaged properly (i.e., alignedproperly).

In some embodiments, the control electronics 414 may provide a detectsignal such as, but not limited to an electronic signal, flag setting,or other indicator to the control electronics 52 and/or the drive device44 upon activation of the responsive device 410 by the interactiveelement 412. In such embodiments, the control electronics 52 and/or thedrive device 44 may be configured to allow operation of the drive device44 only upon the presence of the detect signal.

As discussed above, in certain embodiments, multiple responsive devices410 and interactive elements 412 (and/or first interactive element(s)404, second interactive element(s) 406, sensor(s) 405) may be providedon the first part 401 and the second part 402 and electronicallyconnected to the control electronics 414. In such embodiments, themultiple responsive devices 410 and interactive elements 412 may belocated, for example, at different respective positions around or withinthe first part 401 and the second part 402 to provide multiple alignmentreadings from different locations. In such embodiments, for instance,the control electronics 414 may be configured to provide a detectsignal, for example, to allow operation of the drive device 44 only uponan activation of all or a predefined number or set of the responsivedevices 410.

In further embodiments, the control electronics 414 may be configured toprovide a detect signal, for example, to allow operation of the drivedevice 44 only upon an activation of all or a predefined number or setof the responsive devices 410 in a particular order. For example, thecontrol electronics 414 may be configured to provide a detect signalonly if a first responsive device is activated before, after, orsimultaneously with a second responsive device. In the embodimentsexemplified in FIGS. 29A and 29B, first, the first part 401 and thesecond part 402 may be connected so that the interactive element 412aligns, activates, or otherwise interacts with a first responsive device410 as shown in FIG. 29A. Then the first part 401 may be moved relativeto the second part 402 to align the interactive element 412 with asecond responsive device 410′ shown in FIG. 29B. Such embodiments mayallow, for example, for connection of components in a particularsequence, orientation, and/or in a particular direction.

With reference to FIGS. 24-29B, the control electronics 414 and/or thecontrol electronics 52 (e.g., FIG. 4) may be configured to control thedrive device 44 (e.g., FIG. 4) in various manners in accordance withvarious embodiments of the invention. For example, the drive device 44may be controlled to stop pumping (delivery) operation upon a detectionof an interruption of a fluid-flow path or a disconnection of a criticalcomponent in the delivery device 400. These may include, but are notlimited to, a disconnection of a housing portion from another housingportion or from a base portion, a disconnection of a conduit fromanother conduit or from a reservoir, a disconnection of a reservoir froma housing portion or a base, and/or the like.

In alternative or in addition, the control electronics 414 and/or thecontrol electronics 52 (e.g., FIG. 4) may be configured to detect afirst-time connection of the first part 401 and the second 402 or afirst-time connection of other components, as compared to are-connection after previous or partial usage. In this manner, the drivedevice 44 may be controlled to provide a priming operation or othersuitable first-time operation(s) upon detection of a first-timeconnection of the first part 401 and the second part 402.

In yet further embodiments, additional sensors and/or responsive devices410 a-410 n may be provided within the medical device system 400 andconnected for electrical communication with the control electronics 414.Such additional sensors and/or responsive devices 410 a-410 n maycomprise magnetically and/or electronically actuating switches, magneticand/or electric field magnitude and direction sensors, inductivesensors, other proximity sensors, contact sensors, and/or the like forproviding a detectable signal or change in a state upon properconnection of other components in the medical device system 400. In someembodiments, such additional sensors and/or responsive devices 410 a-410n may be similar to the sensor 205 (or 305) (e.g., FIG. 16-23)previously described. Such proper connection of other components maycomprise, for example, one or more of a proper connection of a reservoirinto a housing portion or base, a proper connection of a conduit to areservoir, a proper connection of two conduits together, a propersetting of a needle or cannula in an inserted state, a proper connectionof a conduit to a cannula or needle, or a proper connection of othercomponents of or to the medical device system 400.

Alternatively, or in addition, the additional sensors and/or responsivedevices 410 a-410 n may include one or more flow detectors for detectingthe occurrence or blockage of a fluid flow path in the infusion device.In such embodiments, the control electronics 414 may be configured toprovide a detect signal, for example, to allow operation of the drivedevice 44 only upon an activation of all or a predefined number or setof the responsive devices 410 and a proper state of the additionalsensors and/or responsive devices 410 a-410 n.

In alternative or in addition, the control electronics 414 and/or thecontrol electronics 52 (e.g., FIG. 4) may be configured to provide auser-perceptible indication of a proper alignment and/or connection ofthe first part 401 and the second part 402 or of other components. Thesemay include, but are not limited to, the connection of a reservoir to ahousing portion 401 or the connection of an injection site module to oneor both of the first part 401 and the second part 402, and/or the like.For example, upon detection of a proper alignment and/or connection ofthe first part 401 and the second part 402, the control electronics 414or 52 may provide a suitable control signal to activate an indicatordevice 420, as shown in FIG. 48.

The indicator device 420 may be operated by a processor 422. Theprocessor 422 may be configured to execute various programs and/or toprocess various information, such as data received from one or moresensors, responsive devices, and/or other interactive elements. Theprocessor 422, for example, may be configured to compare detectedsignals with thresholds and/or pre-stored values in memory 424.

With reference to FIGS. 24-29B and 48, the indicator device 420 mayinclude, but is not limited to, an audible indicator, an opticalindicator, a tactile indicator, combinations of one or more thoseindicators, and/or the like. For example, upon a proper alignment orconnection of components as described above, an audible beeping sound orother suitable sound may be generated by a sound generating device in orassociated with one or both of the first part 401 and the second part402. For example, upon a proper alignment or connection of components asdescribed above, a flashing light or other suitable visual indicator maybe generated by an LED or other light source or a display device on orassociated with one or both of the first part 401 and the second part402. For example, upon a proper alignment or connection of components asdescribed above, a vibration and/or the like may be generated by avibration device and/or the like in or associated with one or both ofthe first part 401 and the second part 402.

In some embodiments, one or more signals may be communicated from atransmitter (not shown) in one of the first part 401 and the second part402 to a remotely located communication device (not shown), such as, butnot limited to, a hand-held controller, a computer, and/or the like.Accordingly, the transmitter may provide one or more of the above-noteduser-perceptible indications to a user of the communication device. Insome embodiments, a text or graphic message may be displayed on adisplay screen on one of the first part 401, the second part 402, and/oron the communication device as an indicator of a proper or improperalignment or connection of the first part 401 and the second part 402.

With reference to FIGS. 1-29B, in various embodiments, a connectionstructure may be provided to secure the first part (e.g., 101, 201, 301,401) and the second part (e.g., 102, 202, 302, 402) together foroperation of the medical device system (e.g., 100, 200, 300, 400) Otherexamples of connection structures are disclosed in the disclosure.Further examples are disclosed in, but not limited to, U.S. patentapplication Ser. No. 11/759,725, entitled “Infusion Medium DeliveryDevice and Method with Drive Device for Driving Plunger in Reservoir”;Ser. No. 12/553,038, filed Sep. 2, 2009, entitled “Insertion DeviceSystems and Methods”; U.S. patent application Ser. No. 12/650,378, filedDec. 30, 2009, all of which are herein incorporated by reference intheir entirety.

In further embodiments, the connection structure may include a magneticstructure for connecting the first part and the second part. Forexample, a magnet may be provided on one of the first part and thesecond part and a magnetically attractive material, such as a magnet ofopposite polarity, a metal, and/or the like may be provided on the otherof the first part and the second part. Such an example as well as otherexamples are disclosed in, but are not limited to, U.S. patentapplication Ser. No. 11/759,725, entitled “Infusion Medium DeliveryDevice and Method with Drive Device for Driving Plunger in Reservoir,”herein incorporated by reference in its entirety.

Various embodiments, additionally or alternatively, may include othersuitable structural features to aid in connecting the first part and thesecond part. These may include, but are not limited to, adhesives,snap-fit structures, friction-fit structures, and/or the like on thefirst part and/or the second part that abut as the first part and thesecond part are brought together for connection. Other examples ofvarious connection structures can be found, but are not limited to, U.S.patent application Ser. No. 12/553,038, filed Sep. 2, 2009, entitled“Insertion Device Systems and Methods,” herein incorporated by referencein their entirety.

Further examples of connection and/or alignment structures are describedwith reference to FIGS. 30A-40B, wherein a medical device system 500 mayincorporate two parts: a first housing portion 530 and a second housingportion 550. Other embodiments may include medical device systems withmore than two parts.

The medical device system 500 may include features similar or may beemployed as an embodiment of the medical device system 100 (e.g., FIGS.7-23), the medical device system 200 (e.g., FIGS. 16-19), the medicaldevice system 300 (e.g., FIGS. 20-23), the medical device system 400(e.g., FIGS. 24-29B), and/or any of the other embodiments described inthe disclosure. Although the medical device system 500 may includefeatures similar or used with the embodiments of FIGS. 7-29B, it shouldbe understood that the medical device system 500 may also include someor all of the same features and operate in a manner similar to thatshown and described in the embodiments of FIGS. 1-6C and/or any of theother embodiments described in the disclosure (e.g., FIGS. 41A-47C). Inaddition, some or all of the features shown in FIGS. 1-29B (and/or anyof the other embodiments described in the disclosure) may be combined invarious ways and included in the embodiments shown in FIGS. 30A-40B.Likewise, it should be understood that any of the features of theembodiments of FIGS. 30A-40B may be combined or otherwise incorporatedinto any of the other embodiments of FIGS. 30A-40B as well as any otherembodiment herein discussed.

In various embodiments, the first housing portion 530 may correspond tothe first part (e.g., 101, 201, 301, and 401 in FIGS. 7-29B) and thesecond housing portion 550 may correspond to the second part (e.g., 101,201, 301, and 401 in FIGS. 7-29B). In particular embodiments, the firsthousing portion 530 may be similar to the durable portion 30 (e.g.,FIGS. 1-6C) and may include (i.e., be integrated with) or be connectedwith the disposable portion 20 (e.g., FIGS. 1-6C). As previouslydiscussed with respect to FIGS. 1-6C, the durable housing portion 530may include various components, such as, but not limited to, a drivedevice 80, drive motor 84, drive device linkage portion 82, and/or thelike. The disposable housing portion 20, which may be integrated orconnected with the first housing portion 530 may include variouscomponents, such as, but not limited to, a reservoir system 40.

Returning to FIGS. 30A-40B, in particular embodiments, the secondhousing portion 530 may be similar to the base (e.g., 21 in FIGS. 1-6C)that may be securable to skin of a patient-user during operation of themedical device system 500. The second housing portion 550 may include(i.e., be integrated with) or be connected with an injection sitesection 503. Examples of injection site sections or modules aredescribed in, but are not limited to, U.S. patent application Ser. No.12/553,008, filed Sep. 2, 2009, entitled “Insertion Device Systems andMethods” and U.S. patent application Ser. No. 12/650,378, filed Dec. 30,2009, both of which are herein incorporated by reference in theirentirety.

The first housing portion 530 may be for securing to the second housingportion 550 and/or the injection site section 503 of the second housingportion 550. In some embodiments, the second housing portion 550 may besecured to the skin of the patient-user before the first housing portion530 is secured to the injection site section 503 and the second housingportion 550. In further embodiments, the first housing portion 530 maybe secured to the second housing portion 550 and/or the injection sitesection 503 of the second housing portion 550 before the second housingportion 550 is secured to the skin of the patient-user.

The second housing portion 550 may include or be connected with areceptacle structure 510 for receiving fluidic media from a reservoir(e.g., reservoir system 40 in FIGS. 1-6C). Various examples ofreceptacle structures as well as connection structures for connectingtwo or more housing portions are described in, but are not limited to,U.S. patent application Ser. No. 12/553,008, filed Sep. 2, 2009,entitled “Insertion Device Systems and Methods,” herein incorporated byreference in their entirety. In some embodiments, the receptaclestructure 510 may be part of the second housing portion 550 adjacent asection of the second housing portion 550 containing the injection sitesection 503. In other embodiments, the receptacle structure 510 mayinclude a housing connected or integrated with the second housingportion 550. In such embodiments, the receptacle structure 510 may beseparate and apart from the injection site section 503 or adjacent theinjection site section 503. In some embodiments, the injection sitesection 503 may be located on a different housing and connected, forexample, with the receptacle structure via a tubing or other fluidconduit.

The second housing portion 550 may include a fluid conduit 524. Thefluid conduit 524 may be (or in fluid communication with), but is notlimited to, a needle, cannula, a piercing member, and/or the like. Thefluid conduit 524 may provide a fluid passage from the receptaclestructure 510 to the injection site section 503. The fluid conduit 524may be supported by a supporting structure located within the receptaclestructure 510. In some embodiments, the supporting structure may be awall integral with the receptacle structure 510. In other embodiments,the supporting structure may be any suitable structure that is generallyfixed relative to the receptacle structure 510 and is able to supportthe fluid conduit 524 in a generally fixed relation to the receptaclestructure 510.

The fluid conduit 524 may be arranged in any suitable manner to conveyfluid, for example, from a reservoir to/from the patient-user. In FIGS.33 and 34, the fluid conduit 524 is arranged to bend around a portion ofthe injection site section 503. As such, in various embodiments, thefluid conduit 524 may be provided on the second housing portion 550 inany suitable manner, including as a straight fluid conduit, a curvedfluid conduit, or the like.

With reference to FIGS. 30A-34, the fluid conduit 524 may be made of anysuitably rigid material, including, but not limited to metal, plastic,ceramic, composite materials, glass, or the like, and may have a hollowchannel extending in a lengthwise dimension of the fluid conduit 524.The hollow channel in the fluid conduit 524 may be open at a location524 a along the lengthwise dimension of the fluid conduit 524, such as,but not limited to, a first end of the fluid conduit 524. The hollowchannel in the fluid conduit 524 may be open at another location 524 balong the lengthwise dimension of the fluid conduit 524, such as, butnot limited to, a second end of the fluid conduit 524 opposite the firstend of the fluid conduit 524. In some embodiments, the opening 524 b ofthe fluid conduit 524 may be connected in fluid flow communication theinjection site section 503.

In some embodiments, one or more of the openings in the fluid conduit524 may be provided with a septum 526 that may be pierceable, forexample, by a sharp end (e.g., 524 b) of the fluid conduit 524. In suchembodiments, the sharp end may be directed toward a surface of theseptum 526 such that the septum 526 may be urged by the first housingportion 530 having a reservoir against the sharp end as the firsthousing portion 530 is connected to the second housing portion 550. Theseptum 526 may be made of any suitable material that may be pierceableby a needle (or the like), such as, but not limited to, a natural orsynthetic rubber material, silicon, or the like. In some embodiments,the septum 526 may be made of a self-sealing material capable of sealingitself after a fluid conduit (and/or the like) has pierced the septum526 and was subsequently withdrawn from the septum 526.

In some embodiments, a septum may be provided with the reservoir. Theseptum may be similar to the septum 526. The septum may be pierceable bya sharp end (e.g., 524 b) of the fluid conduit 524. In such embodiments,the sharp end may be directed toward a surface to allow the sharp end topierce the septum as the first housing portion 530 is connected to thesecond housing portion 550.

The injection site section 503 may include a channel 540 extendingthrough the second housing portion 550. The channel 540 may have an openend 540 a on a bottom surface of the second housing portion 550 (i.e., asurface for contacting skin of the user-patient). The channel 540 mayhave another open end 540 b at an upper surface of the injection sitesection 503 (i.e., a surface opposite the surface for contacting theskin of the user-patient). The channel 540 may have an opening 540 c forallowing the fluid conduit 524, for example via opening 524 b, to be influid flow communication with the channel 540.

The channel 540 may include a channel section 542 having a suitableshape and size to receive an insert structure, a needle, and/or acannula, such as those described in U.S. patent application Ser. No.12/553,008, filed Sep. 2, 2009, entitled “Insertion Device Systems andMethods”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26,2006, titled “Infusion Medium Delivery system, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; and U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, titled “InfusionDevice And Method With Disposable Portion” (each of which is assigned tothe assignee of the present invention), each of which is incorporatedherein by reference in its entirety.

Other examples of various insertion tools are described in U.S. PatentApplication Publication No. 2002/0022855, titled “Insertion Device ForAn Insertion Set And Method Of Using The Same” (assigned to the assigneeof the present invention), which is incorporated herein by reference inits entirety. Other examples of needle/cannula insertion tools that maybe used (or modified for use) to insert a needle and/or cannula, aredescribed in, for example U.S. patent application Ser. No. 10/389,132filed Mar. 14, 2003, and entitled “Auto Insertion Device For SilhouetteOr Similar Products,” and/or U.S. patent application Ser. No. 10/314,653filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set andMethod of Using the Same,” both of which are incorporated herein byreference in their entirety.

Further examples of various insertion tools are described in, but arenot limited to, U.S. patent application Ser. No. 11/645,972, filed Dec.26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; U.S. patent application Ser. No.11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod,” U.S. Pat. Pub. No. US 2007/0142776, entitled “Insertion Devicefor an Insertion Set and Method of Using the Same,” all of which areherein incorporated by reference in their entirety.

The first housing portion 530 may support a reservoir housing 508, whichmay be similar to or include reservoir system 40 (e.g., FIGS. 1-6C) orthe like as previously described. The reservoir housing 508 of the firsthousing portion 530 may include a connection portion 531, which is someembodiments may be a port portion of the reservoir housing 508. Theconnection portion 531 of the reservoir housing 508 may have a suitableshape and size to fit at least partially within an opening 512 of thereceptacle structure 510 in the second housing portion 550 when thesecond housing portion 550 and the first housing portion 530 areconnected together.

In the drawings of FIGS. 30A, 31A, and 32A, the second housing portion550 and the first housing portion 530 are shown in a partiallyseparated, disconnected relation, wherein the connection portion 531 ofthe reservoir housing 508 is outside of the opening 512 of thereceptacle structure 510. By moving or sliding the first housing portion530 in a direction A relative to the second housing portion 550 to bringthe first housing portion 530 and the second housing portion 550together, the connection portion 531 of the reservoir housing 508 can beinserted into the opening 512 of the receptacle structure 510 of thesecond housing portion as shown in FIG. 31B. Continued relative movementof the second housing portion 550 and the first housing portion 530together may cause the fluid conduit 524 to extend into the reservoirhousing 508 as shown in FIG. 32C. In some embodiments, the continuedrelative movement of the second housing portion 550 and the firsthousing portion 530 together may cause a sharp end (e.g., 524 b) of thefluid conduit 524 to pass through one or more septa in the receptaclestructure 510 and/or the reservoir housing 508.

Returning to FIGS. 30A-34, thus when the second housing portion 550 andthe first housing portion 530 are brought together (e.g., FIGS. 30C,31C, 32C) such that the first housing portion 530 is moved to a positionP, at least a portion of the connection portion 531 may extend inside ofthe receptacle structure 510 with the fluid conduit 524 extending intothe interior volume of the reservoir housing 508. Accordingly, the fluidconduit 524 may form a fluid flow path between the interior volume ofthe reservoir housing 508 and the injection site section 503 or otherstructure at the opening 524 b of the fluid conduit 524. In addition oralternatively, the second housing portion 550 may be slidable in thedirection A relative to the first housing portion 530 to bring the twocomponents together.

The receptacle structure 510 and the connection portion 531 may beprovided with mating connectors that provide, for example, a snap orfriction connection upon the second housing portion 550 and the firsthousing portion 530 being connected. In some embodiments, the matingconnectors may include a protrusion (not shown) on one or the other ofthe receptacle structure 510 and the connection portion 531. The otherof the receptacle structure 510 and the connection portion 531 mayinclude a groove or indentation (not shown) arranged to engage eachother in a snap-fitting manner upon the connection portion 531 beingextended into the receptacle structure 510 a suitable distance.

In various embodiments, the second housing portion 550 and the firsthousing portion 530 may be configured to be attachable to and detachablefrom each other, and in specific embodiments to be slidable relative toeach other to operatively engage and disengage each other. That is, thefirst housing portion 530 may be slidable in the direction A relative tothe second housing portion 550 to connect the two components (e.g., thefirst housing portion 530 is in the position P). Similarly, the firsthousing portion 530 may be slidable in a second direction, opposite thedirection A, relative to the second housing portion 550 to disconnectthe two components.

In further embodiments, sliding the first housing portion 530 in thedirection A may allow the reservoir housing 508 of the first housingportion 530 to operatively engage the fluid conduit 524 of the secondhousing portion 550. Thus in some embodiments, a sliding motion, forexample in the direction A, for connecting the first housing portion 530to the second housing portion 550 may be the same sliding motion forconnecting the reservoir housing 508 of the first housing portion 530 tothe fluid conduit 524 of the second housing portion 550. Accordingly,some embodiments may allow for the first housing portion 530 and thesecond housing 550 to be connected and the fluid conduit 524 and thereservoir housing 508 to be connected in a single movement. Suchembodiments may facilitate engagement of the reservoir housing 508 bythe fluid conduit 524.

With reference to FIGS. 30A-34, in some embodiments, the second housingportion 550 may include at least one arm 554, rail, or other raisedsurface that may be used to facilitate connecting (or removal of) thefirst housing portion 530 and the second housing portion 550 in asliding motion. In further embodiments, the arm 554 may include a tab555 fixedly attached or otherwise extending in a cantilevered mannerfrom the arm 554. The arm 554 and the tab 555 may be used to align thesecond housing portion 550 and the first housing portion 530 whileconnecting the two components, as will be further described.Furthermore, the arm 554 and the tab 555 may be used to lock the firsthousing portion 530 to the second housing portion 550, for example, toinhibit separation of the first housing portion 530 from the secondhousing portion 550 in an axial direction transverse to the direction A.Thus, the arm 554 and the tab 555 may prevent the first housing portion530 from falling off or being pulled off the second housing portion 550.Accordingly, in various embodiments, these components provide a coarsehorizontal and/or vertical engagement of the first housing portion 530and the second housing portion 550 toward the front end of the housingportions.

The first housing portion 530 may include at least one groove, cutout,depression, spacing, aperture, and/or the like to facilitate connectionbetween the second housing portion 550 and the second housing portion550. For example, the first housing portion 530 may include an innerdepression 534 for accepting a tab (e.g., tab 555) or other extendedmember disposed on the second housing portion 550.

In some embodiments, to connect the second housing portion 550 and thefirst housing portion 530 together, a tab 534 on the first housingportion 530 may be placed in a depression 558 in the second housingportion 550 as shown in FIGS. 30A, 31A, and 32A. The depression 558 maybe sized liberally, for example larger than a size of the tab 534, sothat the tab 534 may be easily positioned within the depression 558. Thetab 534 may be fixedly attached or otherwise extending from the arm 532of the first housing portion 530.

Once the tab 534 and the arm 534 are in the depression 538, the firsthousing portion 530 may be slid relative to the second housing portion550 in the direction A. By doing so, the tab 555 on the arm 554 on thesecond housing portion 550 may slide into the inner depression 534 ofthe first housing portion 530. Continued relative movement of the secondhousing portion 550 and the first housing portion 530 may allow the tab555 to slide along the inner depression 534 and the adjacent tab 534 ofthe first housing portion 530 as shown in FIGS. 30B, 31B, and 32B. Assuch, the reservoir supported by the first housing portion 530 may beslid or otherwise moved toward the fluid conduit 524 of the secondhousing portion 550 to allow the fluid conduit 524 to engage theinterior volume of the reservoir housing 508 as shown in FIGS. 30C, 31C,32C.

Thus, in some embodiments, the second housing portion 550 and the firsthousing portion 530 may be operatively engaged and the reservoir housing508 and the fluid conduit 524 may be operatively engaged in one motion.In other words, a motion (e.g., sliding motion in the direction A) forengaging the first housing portion 530 to the second housing portion 550may the same motion as a motion for engaging the fluid conduit 524 tothe reservoir. In further embodiments, engagement of the tab 555 of thesecond housing portion 550 and the tab 533 of the first housing portion530 may inhibit separation of the second housing portion 550 and thefirst housing portion 530 in an axial direction transverse to thedirection A.

In addition or alternatively, the second housing portion 550 may beprovided with an arm having a tab and/or depression for receiving an armand/or tab of the first housing portion 530 as previously described.Accordingly, when the first housing portion 530 and the second housingportion 550 are slid relative to each other, for example, in thedirection A, the first housing portion 530 and the second housingportion 550 may be operatively engaged in a manner as previouslydescribed.

In further embodiments, the second housing portion 550 may be providedwith a stop surface 556 to prevent further movement of the first housingportion 530 relative to the second housing portion 550, for example,after the fluid conduit 524 has sufficiently engaged the interior volumeof the reservoir housing 508 (e.g., the first housing portion is movedto position P). For instance, a portion of the first housing portion 530may contact the stop surface 556 after the first housing portion 530 hasbeen sufficiently advanced to substantially prevent the first housingportion 530 from further advancement. Such embodiments, may allow foradditional protection of the reservoir housing 508 and/or the fluidconduit 524 from damage due to excessive force, speed, and/or the likein connecting the second housing portion 550 and the first housingportion 530. In other embodiments, a stop surface 536 may be provided onthe first housing portion 530 in addition or in alternative to the stopsurface 556 of the second housing portion 550.

In some embodiments, the arm 532 and/or other portion of the firsthousing portion 530 may include a cutout, depression, or surface (notshown) that may aid a user-patient in gripping the first housing portion530 during the connection process. In some embodiments, a portion of thesecond housing portion 550 may include a cutout, depression, or surface(not shown) that may aid a user-patient in gripping the second housingportion 550 during the connection process.

With reference to FIGS. 35A-36B, in some embodiments, a dovetailconnection structure may be provided for connecting the first housingportion 530 and the second housing portion 550. Accordingly, thedovetail connection structure may provide fine vertical alignmentbetween the first housing portion 530 and the second housing portion 550at the rear of the housing portions. For example, one of the firsthousing portion 530 and the second housing portion 550 may have a groove562 for receiving a protruding surface or dovetail 542 on the other ofthe first housing portion 530 and the second housing portion 550. Aportion of the dovetail 542 may be placed in the groove 562 or slid intothe groove 562. Further movement (e.g., in a sliding motion) of thedovetail 542 in the direction A along the groove 562 may connect thefirst housing portion 530 and the second housing portion 550 in a mannerpreviously described. In some embodiments, the groove 562 and/or thedovetail 542 may be tapered to facilitate placement of the dovetail 542in the groove 562.

In some embodiments, the groove 562 or the dovetail 542 may be taperedto secure the dovetail 542 in the groove 562, for example, in a frictionfit as the dovetail 542 is advanced along the groove 562 in thedirection A. For example, as shown in FIGS. 35A and 35B, a widthdimension of a groove 564 may be largest opposite the front end 552 ofthe second housing portion 550 and may taper to a narrow width dimensionin a direction of the direction A. Accordingly, such embodiments mayallow for facilitating placement of the dovetail 542 in the groove 564,aligning of the first housing portion 530 as the dovetail 542 is guidedby a surface defining the groove 564, and/or securing the dovetail 542against the surface defining the groove 564 in a friction fit manner. Inaddition or alternatively, a groove 564 may be provided in the firsthousing portion 530 and a dovetail 542 may be provided on the secondhousing portion 550 in a manner previously described.

As another example shown in FIGS. 36A and 36B, a dovetail 544 may betapered such that a front end of the dovetail 544 is narrower than arear portion of the dovetail 544. Accordingly such embodiments, mayallow for facilitating placement of the dovetail 544 in the groove 562,aligning of the first housing portion 530 as the dovetail 544 is guidedby a surface defining the groove 562, and/or securing the dovetail 544against the surface defining the groove 562 in a friction fit manner. Inaddition or alternatively, a groove 562 may be provided in the firsthousing portion 530 and a dovetail 544 may be provided on the secondhousing portion 550 in a manner previously described.

Returning to FIGS. 30A-34, in some embodiments, the arm 554 and/or thetab 555 may be angled relative to the second housing portion 550 toprovide further alignment while connecting the first housing portion 530to the second housing portion 550. For example, the arm 554 and/or thetab 55 may be angled outwardly (relative to the front end 552 of thesecond housing portion 550) to facilitate engagement with the arm 532,tab 534, and/or inner depression 533 of the first housing portion 530.As such, the arm 532 of the first housing portion 530 need only beplaced in the depression 558 and advanced in the direction A to allowthe tab 534 and/or the inner depression 533 to meet the angled arm 554and/or tab 555 at which point the angled arm 554 and/or tab 555 mayguide the arm 532 of the first housing portion 530 with continuedmovement of the first housing portion 530. In such embodiments, the arm532, the tab 534, and/or the entire first housing portion 530 may bemade of a sufficiently flexible material, such as plastic, a compositematerial, and/or the like, to allow some flexing as the portion of thefirst housing portion 530 moves along the angled arm 554 and/or tab 555.

In some embodiments, such as the embodiments shown in FIGS. 33 and 34,one more rails 559, ridges, or other raised surfaces may be provided onthe second housing portion 550 to guide the first housing portion 530along the second housing portion 550. Accordingly, in variousembodiments, the rails 559 may provide initial coarse horizontalalignment between the first housing portion 530 and the second housingportion 550 at the rear of the housing portions. The rails 559 may beparallel or nonparallel to each other. The rails 559 may define anopening 557 through which the first housing portion 530 may be slid. Insome embodiments, the rails 559 may be on a periphery (either a portionor an entirety thereof) of the second housing portion 550, and in someembodiments, the rails 559 may be arranged at any suitable location(e.g., internal or away from the periphery) along the second housingportion 550 (and/or first housing portion 530), such as those described,for example, in FIGS. 37A-38C. In further embodiments, the first housingportion 530 may include arms (not shown) or the like for engaging therails 559 to provide coarse vertical alignment between the first housingportion 530 and the second housing portion 550 at the rear of thehousing portions.

In further embodiments, the rails 559 may be arranged to facilitatealignment and/or connection of the second housing portion 550 and thefirst housing portion 530. For example, opposing rails 559 may bearranged on the second housing portion 550 to be nonparallel to eachother, as shown in, for example, FIGS. 37A-38C. The rails 559 may beangled inwardly (toward the front end 552 of the second housing portion550) to provide a liberally sized opening 557 having a width dimensionlarger than a width dimension of the first housing portion 530 (or atleast larger than a width dimension of a front portion of the firsthousing portion 530) so that the first housing portion 530 may bepositioned easily within the opening 557. Accordingly, the first housingportion 530 may be advanced in the direction A toward the front end 552of the second housing portion 550. In a case where, the first housingportion 530 is being advanced toward the front end 552 and is slightlymisaligned, a portion of the first housing portion 530 may contact(e.g., FIG. 37B) at least one of the rails 559 at which point thecontacted rail 559 may guide the first housing portion 530 toward analigned position with continued movement of the first housing portion530 in the direction A.

In other embodiments, the rails 559 may be parallel to each other witheach of the rails 559 having a surface 559 a that is nonparallel to asurface 559 a of the other rail 559. As shown in FIGS. 38A-38C, thesurface 559 a of each of the rails 559 may face each other. Accordingly,the first housing portion 530 may be advanced in the direction A towardthe front end 552 of the second housing portion 550. In a case where,the first housing portion 530 is being advanced toward the front end 552and is slightly misaligned, a portion of the first housing portion 530may contact (e.g., FIG. 38B) at least one of surfaces 559 a of the rails559 at which point the contacted surface 559 a may guide the firsthousing portion 530 toward an aligned position with continued movementof the first housing portion 530 in the direction A.

Thus, various embodiments that include one or rails 559 may allow forsome lateral misalignment at a beginning of the sliding motion (e.g., asthe first housing portion 530 is moved in the direction A). Suchembodiments additionally may allow for forcing or guiding the firsthousing portion 530 into proper alignment with the second housingportion 550 as the sliding motion proceeds in the direction A.

With reference to FIGS. 37A-38C, in further embodiments, once the firsthousing portion 530 is placed in the aligned position by the rails 559,the first housing portion 530 and the second housing 550 may engage eachother in a manner previously described with respect to FIGS. 30A-36B.For example, the arm 554 and tab 555 of the second housing portion 550may engage the arm 532 of the first housing portion 530 as the firsthousing portion 530 is slid in the direction A. As another example, adovetail (e.g., 542) of the first housing portion 530 may engage asurface defining a groove (e.g., 562) of the second housing portion 550.

With reference to FIGS. 30A-38C, in further embodiments, at least onemagnet (not shown) may be provided on one or both of the second housingportion 550 and the first housing portion 530 along with an magneticallyattractive material (not shown), such as, but not limited to, metal, amagnet having an opposing pole, or the like, on the other of the secondhousing portion 550 and the first housing portion 530. Each of themagnet(s) and the magnetically attractive material may be arranged at alocation to interact with each other upon the second housing portion 550and the first housing portion 530 being connected properly or otherwisebrought into a pre-defined, sufficiently aligned position and/or in apre-defined, sufficiently close proximity. The predefined alignedposition and/or proximity, for example, may correspond to a properlyaligned and mutually proximate position for connection of the firsthousing portion 530 and the second housing portion 550 for operation.

The magnets and the magnetically attractive material may be provided atone or more locations to interact with each other upon the first housingportion 530 being moved to the position P (or other position) relativeto the second housing portion 550. For instance, in a case where thefirst housing portion 530 is moved to the position P, the magnet on oneof the housing portions may interact with the magnet (or attractivematerial) on the other of the housing portions, for example, to connectand/or align the housing portions. Examples of magnetic connection andalignments structures and other alignment and connection structures willbe described later and are also described in, but are not limited to,U.S. patent application Ser. No. 11/759,725, filed Jun. 7, 2007,entitled “Infusion Medium Delivery Device and Method with Drive Devicefor Driving Plunger in Reservoir,” herein incorporated by reference inits entirety.

In some embodiments, such as the embodiments shown in FIGS. 39A and 39B,the first housing portion 530 and the second housing portion 550 mayinclude magnets configured to align, for example laterally, the firsthousing portion 530 and the second housing portion 550 in a case wherethe first housing portion 530 and the second housing portion are beingconnected and are misaligned. For instance, the magnets may be arrangedto oppose each other in a case where the first housing portion 530 andthe second housing portion 550 are misaligned. For example, the magnetsmay each have surfaces having similar pole directions. For instance, amagnet 582 supported by the first housing portion (not shown in FIGS.39A and 39B) may be opposed to one or more magnets 572 supported on thesecond housing portion 550. For example, the magnet 582 may have asurface have a first polarity (e.g., North), and the one or more magnets572 may each have a surface having a polarity (e.g., North) similar tothe first polarity of the magnet 582.

In some embodiments, the one or more magnets 572 may comprise a firstmagnet 574 a and a second magnet 574 b. A spacing 573 may be providedbetween the first magnet 574 a and the second magnet 574 b. In suchembodiments, the first housing portion and the second housing portion550 may be connected, for example, in a slidable manner as previouslydescribed. The magnet 582 may be guided along the one or more magnets572 as the first housing portion is moved in the direction A. Forexample, the magnet 582 may move between the first magnet 574 a and thesecond magnet 574 b over the spacing 573. In such embodiments, lateralmisalignment of the first housing portion and the magnet 582 may beinhibited by the opposing one or more magnets 572.

In further embodiments, such as that shown in FIGS. 40A and 40B, the oneor more magnets 572 supported on the second housing portion 550 mayinclude a third magnet 576 that is attracted to the magnet 582 supportedby the first housing portion (not shown in FIGS. 40A and 40B). Forexample, the third magnet may have a second polarity (e.g., South)opposite the first polarity of the magnet 583. In some embodiments, theone or magnets 572 may include a magnetically attractive material (asopposed to a magnet), such as a metal, ferrous conduit, or the like.

In various embodiments, the first housing portion 530 and the secondhousing portion 550 may be connected, for example, in a slidable manneras previously described. The magnet 582 (and/or the magneticallyattractive material) may be guided along the one or more magnets 572 asthe first housing portion is moved in the direction A. For example, themagnet 582 may move between the first magnet 574 a and the second magnet574 b over the third magnet 576. In such embodiments, lateralmisalignment of the first housing portion and the magnet 582 may beinhibited by the opposing one or more magnets 572 and/or by theattraction between the magnet 582 and the third magnet 576 (and/or themagnetically attractive material).

With reference to FIGS. 39A-40B, in some embodiments, the magnets (e.g.,582, 572) may be arranged in a manner described with respect to, forexample (but not limited to), the rails 559 and dovetail structuresdescribed in FIGS. 35A-38C. For instance, returning to FIGS. 39A-40B,the first magnet 574 a and the second magnet 574 b may be arranged to benon-parallel to each other (e.g., as described in FIGS. 37A-38C). Asanother example, the first magnet 574 a and the second magnet 57 b maybe arranged to taper such that the spacing 573 narrows in the directionA, for example, as described in FIGS. 35A-36B.

With reference to FIGS. 30A-40B, in some embodiments, at least one latch(not shown), or the like may be provided on one of the second housingportion 550 and the first housing portion 530. The latch (e.g., 1038 inFIGS. 54A and 54B) may be configured to engage an aperture 568, cavity,engagement member, and/or the like in the other of the second housingportion 550 and the first housing portion 550 upon the second housingportion 550 and the first housing portion 530 being operatively engaged(e.g., the first housing portion 530 moved toward the position P).

In further embodiments, the latch may be configured to manually engageand/or disengage the aperture 568 (or the like). For instance, the latch(or portion of the housing portion on which the latch is provided) maybe configured to be squeezable (e.g., pressed inward relative to thehousing portions) to allow the first housing portion 530 to engageand/or disengage from the second housing portion 550. For example, alatch may be provided on each side of the first housing portion 530 suchthat a squeezing motion of the latches (e.g., toward each other) mayallow each of the latches to be released from a corresponding aperture568 (or the like) to allow the first housing portion 530 to be removedfrom the second housing portion 550.

In yet further embodiments, the latch may be configured to force thefirst housing portion 530 and the second housing portion 550 apart in acase where the first housing portion 530 and the second housing portion550 are not properly connected. For example, in a case where the firsthousing portion 530 is not slid sufficiently relative to the secondhousing portion 550 (in the direction A) so that the latch engages theaperture, the latch may force the first housing portion 530 in anopposite direction (to the direction A) to further separate the firsthousing portion 530 and the second housing portion 550. Accordingly, theconnection process may be re-attempted until the latch engages theaperture. In particular embodiments, a bias member (not shown), such asa spring, resilient material, and/or the like, may be provided withand/or comprise the latch. The bias member may bias the first housingportion 530 away from the second housing portion 550, for example, in adirection opposite the direction A. As such, in a case where the firsthousing portion 530 is moved sufficiently in the direction A relative tothe second housing portion 550, the latch may engage the aperture (orthe like). Whereas in a case where the first housing portion 530 is notmoved sufficiently in the direction A relative to the second housingportion 550, the bias member may urge the first housing portion 530apart from the second housing portion 550, for example, in the oppositedirection to the direction A to allow the user-patient to repeat theconnection process.

Returning to FIG. 33, in some embodiments, the latch may be a tab orprotrusion (e.g., 1038 in FIGS. 54A and 54B). The tab may be flexible orsupported on a portion of the first housing portion 530 that isflexible. A recess 566 of the second housing portion 550 may be forreceiving tab of the first housing portion 530 during the initialengagement of the first housing portion 530 and the second housingportion 550. In FIG. 33, the recess 566 is provided on a rear portion ofthe second housing portion 550, but in other embodiments, the recess 566may be provided at any suitable location. During the sliding connectionof the first housing portion 530 and the second housing portion 550 aspreviously described, the tab may be received by the recess 566 andguided by a surface (e.g., protrusion 567) defining at least a portionof the recess 566.

A protrusion 567 may be arranged on the second housing portion 550 todirect or flex the tab inwardly (or outwardly) as the first housingportion 530 moves (e.g., slides) in the direction A. That is, theprotrusion 567 may be arranged to direct or flex the tab in a directiontransverse to the direction A. Continued movement of the first housingportion 530 in the direction A beyond the protrusion 567 may allow thetab to flex in the opposite direction into the cavity 568 or an abutmentor other engagement member in or defining the cavity 568 of the secondhousing portion 550.

The dimensions of the first housing portion 530 and the second housingportion 550 and arrangement of the recess 566, cavity 568, and tab maybe selected such that the tab enters the cavity 568 upon the firsthousing portion 530 being toward the position P. As discussed, movingthe first housing portion 530 toward the position P may allow, forexample, the fluid conduit 524 to engage with (i.e., be in fluidcommunication with) the interior volume of the reservoir housing 508.

The tab may remain in the cavity 568 until the patient-user pushes thetab inwardly (or outwardly) to clear the protrusion 567. Accordingly,the first housing portion 530 may be moved in the opposite directionfrom the direction A, for example, to disengage the first housingportion 530 and the second housing portion 550. In additional oralternatively, the first housing portion 530 may have a recess forreceiving a tab of the second housing portion 550 in a slidable mannerwith a protrusion and a cavity for retaining the tab in a mannerpreviously described. In some embodiments, the tab and the recess 566may be the dovetail (e.g., 542) and the groove (e.g., 562) as described,for example, with respect to FIGS. 35A-36B.

In some embodiments, a sensor (not shown) may be provided for sensingthe latch and/or a relative position of the latch and/or a portion ofthe latch, for example a detectable feature (e.g., an interactiveelement as discussed in the disclosure) of the latch or provided on thelatch. As such, the sensor can determine whether the latch has properlyengaged the aperture (or the like) to determine that the second housingportion 550 and the first housing portion 530 have been properlyconnected (e.g., the first housing portion 530 is in the position P).Examples of sensors, detectable features, interactive elements, and thelike are described in the disclosure and in, but not limited to, U.S.patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled“Alignment Systems and Methods,” herein incorporated by reference in itsentirety.

Suitable electronics may be connected to the sensor to provide acontrolled power signal to selectively activate or otherwise control oneor more of the sensor and/or other components as described in thedisclosure. For example, the sensor may be controlled to activate upon amanual activation of a control button, switch, or other manual operatoron one of the connectable components or on a remote-controller device(not shown) connected in wireless communication with the sensor throughsuitable control electronics. As another example, the sensor may becontrolled to activate automatically after a certain action, such asactivation of a button, and/or the like or after a certain amount oftime. In some embodiments, the sensor may be controlled to activate uponactivation or insertion of a particular component or device, such as,but not limited to, a needle inserter to insert a needle or cannula.

Examples of various needle insertion tools are described in, but are notlimited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; U.S. patent application Ser. No. 11/645,435, filedDec. 26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method,” all of which are herein incorporated byreference in its entirety. Thus, in such examples, the sensor may beactivated, for example, before or after, the first housing portion 530and the second housing portion 550 are brought operatively engaged.

Further examples of connection and/or alignment structures are describedwith reference to FIGS. 41A-43B, wherein a medical device system 900 mayincorporate two parts: a first housing portion 901 and a second housingportion 902. Other embodiments may include medical device systems withmore than two parts.

The medical device system 900 may be similar to or employed as anembodiment of the medical device system 500 (e.g., FIGS. 30A-40B) and/orthe other medical device systems discussed in the disclosure. Althoughthe medical device system 900 may include features similar or used withthe embodiments of FIGS. 30A-40B, it should be understood that themedical device system 900 may also include some or all of the samefeatures and operate in a manner similar to that shown and described inthe embodiments of FIGS. 1-29B and/or any of the other embodimentsdescribed in the disclosure (e.g., FIGS. 44A-47C). In addition, some orall of the features shown in FIGS. 1-40B (and/or any of the otherembodiments described in the disclosure) may be combined in various waysand included in the embodiments shown in FIGS. 41A-43B. Likewise, itshould be understood that any of the features of the embodiments ofFIGS. 41A-43B may be combined or otherwise incorporated into any of theother embodiments of FIGS. 41A-43B as well as any other embodimentherein discussed.

In various embodiments, the first housing portion 901 may be, but is notlimited, to any of the housing portions described, such as the durableportion 30 (e.g., FIGS. 1-6C) and the disposable portion 20 (e.g., FIGS.1-6C). In specific embodiments, the first housing portion 901 may besimilar to the first housing portion 530 (e.g., FIGS. 30A-40B).

Moreover in various embodiments, the second housing portion 902 may be,but is not limited, to any of the housing portions described, such asthe base 21 (in FIGS. 1-6C), the durable housing portion 30, and thedisposable housing portion. In specific embodiments, the second housingportion 902 may be similar to the second housing portion 550 (e.g.,FIGS. 30A-40B). In such embodiments, for example, the second housingportion 902 may be secured to skin of a patient-user or otherwisecarried by the patient-user (e.g., secured on a belt, clothing, or thelike) during operation of the medical device system 900.

The first housing portion 901 may include a plurality of electricalcontacts 910 including a first main electrical contact 912 and a secondmain electrical contact 916. The plurality of electrical contacts 910may also include one or more other electrical contact 914. Theelectrical contacts 910 may me made of any suitable material such asmetal, a rubber conductive pad, as well as any other electricalconductor.

In some embodiments, the other electrical contact 914 may be arrangedbetween the first main electrical contact 912 and the second mainelectrical contact 916. However, the other electrical contact 914 may bearranged at any suitable location. The other electrical contact 914 maybe made of the same material as the first main electrical contact 912and/or the second main electrical contact 914. In other embodiments, theother electrical contact 914 may be made of a different material (e.g.,a different conductive material, or a non-conductive material) from thefirst main electrical contact 912 and/or the second main electricalcontact 914.

The second housing portion 902 may include a shorting mechanism 920 orthe like configured to establish a short or electrical connection withat least some of the electrical contacts 910 upon connecting the firsthousing portion 901 and the second housing portion 902. In someembodiments, the shorting mechanism 920 may establish an electricalconnection with at least some of the electrical contacts 910 in a casewhere the first housing portion 901 and the second housing portion 902are connected properly or otherwise brought into a pre-defined,sufficiently aligned position and/or in a pre-defined, sufficientlyclose proximity. The predefined aligned position and/or proximity, forexample, may correspond to a properly aligned and mutually proximateposition for connection of the first housing portion 901 and the secondhousing portion 902 for operation. In other embodiments, the shortingmechanism 920 may be a known resistance or the like.

The shorting mechanism 920 may have a first end 922 and a second end 924for contacting respective electrical contacts 910 on the first housingportion 901. In some embodiments, the first end 922 and the second end924 may be arranged to contact the first main electrical contact 912 andthe second main electrical contact 916 respectively when the firsthousing portion 901 and the second housing portion 902 are connectedproperly, for example, as shown in FIG. 41B. As such, the shortingmechanism 920 may contact the first main electrical contact 912 and thesecond main electrical contact 916, but not the other electrical contact914. Suitable circuitry (not shown) connected to the electrical contacts910 may be configured to detect an electrical connection or shortbetween the first main electrical contact 912 and the second mainelectrical contact 916 (via the shorting mechanism 920) indicating aproper connection of the first housing portion 901 and the secondhousing portion 902.

Furthermore, the electrical contacts 910 and/or the shorting mechanism920 may be arranged on their respective parts such that in a case wherethe first housing portion 901 and the second housing portion 902 are notproperly connected, such as in FIG. 41C, an electrical connectionbetween the first main electrical contact 912 and the second mainelectrical contact 916 is not established. Accordingly, this mayindicate that the first housing portion 901 and the second housingportion 902 have not been connected properly.

Returning to FIGS. 41A-41C, some embodiments in which at least one otherelectrical contact 914 is arranged between the first main electricalcontact 912 and the second main electrical contact 916 may prevent afalse detection of a proper connection of the first housing portion 901and the second housing portion 902. For example, the circuitry may beable to distinguish between a case where a stray metal object (e.g., ametal key, paper clip, coin) or other electrical conductor contacts thefirst main electrical contact 912, the second main electrical contact916, and the other contact 914 as opposed to a proper connection whereonly the first main electrical contact 912 and the second mainelectrical contact 912 are contacted (by the shorting mechanism).

In some embodiments, an electrical connection will only be establishedwhen the first end 922 contacts the first main electrical contact 912and the second end 924 contacts the second main electrical contact 916.In other embodiments, an electrical connection may be established in acase where the first end 922 and the second end 924 contact the firstmain electrical contact 912 and the second main electrical contact 916respectively or in a case where the first end 922 and the second end 924contact the second main electrical contact 916 and the first mainelectrical contact 912 respectively. Such embodiments, may allow for adetection of a proper connection of the first housing portion 901 andthe second housing portion 902 in more than one orientation.

In the embodiments shown in FIGS. 41A-41C, there are three electricalcontacts: the first main electrical contact 912, the second mainelectrical contact 916, and the other electrical contact 914 arrangedbetween the first main electrical contact 912 and the second mainelectrical contact 916. However, in various other embodiments, anysuitable number of electrical contacts 910 may be provided on the firsthousing portion 901 as required. In some embodiments, the mainelectrical contacts (e.g., 912, 916) are arranged as the outermostelectrical contacts; however, in other embodiments, the main electricalcontacts may be arranged anywhere relative to the other electricalcontact(s) 914.

Similarly, the other electrical contacts need not be limited to beingarranged in between main electrical contacts, but may also be arrangedto be the outermost electrical contact in some embodiments. As such, theelectrical contacts 910 (e.g., main electrical contacts and otherelectrical contacts) may be arranged or otherwise provided on the firsthousing portion 901 in any suitable manner, for examplelinearly/non-linearly, equidistant/non-equidistant, similar/varyingheights, arranged on similar/varying surfaces, same/differentresistances, same/different materials, and/or the like. For instance, asshown in FIG. 42, seven electrical contacts 910 could be providedincluding two first main electrical contacts 912, a first otherelectrical contact 914, a second main electrical contact 916, a secondother electrical contact 914, and two third main electrical contacts918.

In the embodiments shown in FIGS. 41A-41C, the shorting mechanism 920has two ends 922, 924 for contacting the first main electrical contact912 and the second main electrical contact 916, respectively. However,in various other embodiments, the shorting mechanism 920 may be providedwith any suitable number of ends or contact surfaces for contacting theelectrical contacts 910 as required. Similarly, the ends (e.g., 922,924) may be arranged on shorting mechanism 920 in any suitable manner.

In various embodiments, the electrical contacts 910 may be provided onthe first housing portion 901 and the shorting mechanism 920 may beprovided on the second housing portion 902. In other embodiments, theelectrical contacts 910 may be provided on the second housing portion902 and the shorting mechanism 920 may be provided on the first housingportion 901. In further embodiments, each of the first housing portion901 and the second housing portion 902 may be provided with a shortingmechanism 920 and complementing electrical contacts 910.

In some embodiments, such as the embodiments shown in FIGS. 43A and 43B,a bias member 919, such as a spring, or the like, may be provided tobias the electrical contacts 910 either individually, partially (e.g.,some, but not all), or collectively toward a first position (e.g., anextended position as shown in FIG. 43A). As such, the electricalcontacts 910 may be moveable toward a second position (e.g., a retractedposition as shown in FIG. 43B), for example, as the first housingportion 901 and the second housing portion 902 are brought together.Thus, while in the second position, an electrical connection may beestablished between the first main electrical contact 912 and the secondmain electrical contact 916 via the shorting mechanism 910 in a similarmanner to that previously described. The bias member 919 may be locatedat least partially within a recess of the first housing portion 901. Insome embodiments, the bias member 919 may be supported on the firsthousing portion 901, for example, between the electrical contacts 910and the first housing portion 901.

In addition or in alternative to the above, in some embodiments, a biasmember, such as a spring, or the like, may be provided to bias theshorting mechanism or portion thereof (e.g., ends 922, 924) toward afirst position (e.g., an extended position). As such, shorting mechanismor portion thereof may be moveable toward a second position (e.g., aretracted position), for example, as the first housing portion 901 andthe second housing portion 902 are brought together. Thus, while in thesecond position, an electrical connection may be established between thefirst main electrical contact 912 and the second main electrical contact916 via the shorting mechanism 910 in a similar manner to thatpreviously described.

In various embodiments, the electrical contacts 920 and/or the shortingmechanism 910 may be or otherwise comprise a bias member like thatpreviously described. For example, the electrical contacts 920 may bemetal springs or the like that may be moveable from the first positionto the second position as the first housing portion 901 and the secondhousing portion 902 are brought together.

Further examples of connection and/or alignment structures are describedwith reference to FIGS. 44A-45B, wherein a medical device system 1100may incorporate two parts: a first housing portion 1101 and a secondhousing portion 1102. Other embodiments may include medical devicesystems with more than two parts.

The medical device system 1100 may be similar to or employed as anembodiment of the medical device system 500 (e.g., FIGS. 30A-40B), themedical device system 900 (e.g., FIGS. 41A-43B), and/or the othermedical device systems discussed in the disclosure. Although the medicaldevice system 1100 may include features similar or used with theembodiments of FIGS. 30A-43B, it should be understood that the medicaldevice system 1100 may also include some or all of the same features andoperate in a manner similar to that shown and described in theembodiments of FIGS. 1-29B and/or any of the other embodiments describedin the disclosure (e.g., FIGS. 46A-47C). In addition, some or all of thefeatures shown in FIGS. 1-43B (and/or any of the other embodimentsdescribed in the disclosure) may be combined in various ways andincluded in the embodiments shown in FIGS. 44A-45B. Likewise, it shouldbe understood that any of the features of the embodiments of FIGS.44A-45B may be combined or otherwise incorporated into any of the otherembodiments of FIGS. 44A-45B as well as any other embodiment hereindiscussed.

In various embodiments, the first housing portion 1101 may be, but isnot limited, to any of the housing portions described, such as thedurable portion 30 (e.g., FIGS. 1-6C) and the disposable portion 20(e.g., FIGS. 1-6C). In specific embodiments, the first housing portion1101 may be similar to the first housing portion 530 (e.g., FIGS.30A-40B).

Moreover in various embodiments, the second housing portion 1102 may be,but is not limited, to any of the housing portions described, such asthe base 21 (FIGS. 1-6C), the durable housing portion 30, and thedisposable housing portion. In specific embodiments, the second housingportion 1102 may be similar to the second housing portion 550 (e.g.,FIGS. 30A-40B). In such embodiments, the second housing portion 1102 maybe secured to skin of a patient-user during operation of the medicaldevice system 1100.

The first housing portion 1101 may include a sensor 1110 for sensing amagnetic field, and in specific embodiments, for sensing at least adirection (i.e., vector) of a magnetic field. Such sensors 1110 mayallow for detecting a presence of a magnetic field or magnetic sourceindependent of magnetic strength. Furthermore, sensing a direction of amagnetic field may increase the probability that the sensor 1110 issensing the appropriate the magnetic source. The sensor 1110 may besimilar to the sensors described in, but is not limited to, U.S. patentapplication Ser. No. 12/649,619, filed Dec. 30, 2009, entitled“Alignment Systems and Methods,” herein incorporated by reference in itsentirety. The sensor 1110 may be disposed in the first housing portion1101 or be provided on the first housing portion 1101.

Suitable electronics may be connected to the sensor 1110 to provide acontrolled power signal to selectively activate or otherwise control oneor more of the sensor 1110 and/or other components as described in thedisclosure. For example, the sensor 1110 may be controlled to activateupon a manual activation of a control button, switch, or other manualoperator on one of the connectable components or on a remote-controllerdevice (not shown) connected in wireless communication with the sensor1110 through suitable control electronics. As another example, thesensor 1110 may be controlled to activate automatically after a certainaction, such as activation of a button, and/or the like or after acertain amount of time. In some embodiments, the sensor 1110 may becontrolled to activate upon activation or insertion of a particularcomponent or device, such as, but not limited to, a needle inserter toinsert a needle or cannula.

Examples of various needle insertion tools are described in, but are notlimited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; U.S. patent application Ser. No. 11/645,435, filedDec. 26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method,” all of which are herein incorporated byreference in their entirety. Thus, in such examples, the sensor 1110 maybe activated, for example, before or after, the first housing portion1101 and the second housing portion 1102 are brought operativelyengaged.

The second housing portion 1102 may include a magnetic source 1120 orthe like for providing a magnetic field having a direction. The magneticsource 1120 may be arranged on or in the second housing portion 1102 ata location to allow the magnetic field and/or the direction of themagnetic field of the magnetic source 1120 to be detectable by thesensor 1110 in a case where the first housing portion and the secondhousing portion 1102 are connected properly or otherwise brought into apre-defined, sufficiently aligned position and/or in a pre-defined,sufficiently close proximity. The predefined aligned position and/orproximity, for example, may correspond to a properly aligned andmutually proximate position for connection of the first housing portion1101 and the second housing portion 1102 for operation. Detection of themagnetic field and/or the direction of the magnetic field of themagnetic source 1120 may indicate that the first housing portion 1101and the second housing portion 1102 have been connected properly.

In some embodiments, the magnetic source 1120 may be in contact with thesensor 1110 to allow the sensor 1120 to detect the magnetic field and/ordirection of the magnetic field of the magnetic source 1120. In otherembodiments, the magnetic source 1120 need not be in contact with thesensor 1110 to allow the sensor 1110 to detect the magnetic field and/ordirection of the magnetic field of the magnetic source 1120. Forexample, a portion of one or both of the first housing portion 1101 andthe second housing portion 1102 may be arranged between the sensor 1110and the magnetic source 1120.

Furthermore, the sensor 1110 and the magnetic source 1120 may bearranged such that in a case where the first housing portion 1101 andthe second housing portion 1102 are not been properly connected, thesensor 1110 will not be able to detect the magnetic field and/or thedirection of the magnetic field, for example, because the sensor 1110and the magnetic source 1120 are too far apart. Accordingly, this mayindicate that the first housing portion 1101 and the second housingportion 1102 have not been connected properly.

In some embodiments, the magnetic source 1120 may provide more than onemagnetic fields and/or directions of magnetic fields. As shown forexample in FIGS. 44A and 44B, a first field 1122, a second field 1124,and a third field 1126 are provided in which the first field 1122 andthe third field 1126 have a direction different from a direction of thesecond field 1124. In such an example, the sensor 1110 may be configuredto detect only the second field 1124 and/or the direction (e.g., North)of the second field 1124 in a manner previously described. Thus,detection of the second field 1124 and/or the direction of the secondfield 1124 may indicate that the first housing portion 1101 and thesecond housing portion 1102 have been connected properly.

In further embodiments, the sensor 1110 may be configured to detectother fields (e.g., first field 1122 and second field 1126) and/ordirections of the other fields such that detection of the other fieldsand/or directions of the other fields may indicate an improperconnection of the first housing portion 1101 and the second housingportion 1102. The electronics may employ an algorithm for processinginformation relating to the various fields and/or other relatedinformation (e.g., magnetic field strength, gauss level, and/or thelike).

In some embodiments, such as the embodiments shown in FIGS. 45A-45B, thefirst housing portion 1101 may have a sensor 1111 for sensing a gausslevel or the like of a magnetic source. The sensor 1111 may be similarto the sensor 1110 previously described or any of the sensors describedin, but is not limited to, U.S. patent application Ser. No. 12/649,619,filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” hereinincorporated by reference in its entirety. The sensor 1111 may bedisposed in the first housing portion 1101 or be provided on the firsthousing portion 1101.

Suitable electronics may be connected to the sensor 1111 to provide acontrolled power signal to selectively activate or otherwise control oneor more of the sensor 1111 and/or other components as described in thedisclosure. For example, the sensor 1111 may be controlled to activateupon a manual activation of a control button, switch, or other manualoperator on one of the connectable components or on a remote-controllerdevice (not shown) connected in wireless communication with the sensor1111 through suitable control electronics. As another example, thesensor 1111 may be controlled to activate automatically after a certainaction, such as activation of a button, and/or the like or after acertain amount of time. In some embodiments, the sensor 1111 may becontrolled to activate upon activation or insertion of a particularcomponent or device, such as, but not limited to, a needle inserter toinsert a needle or cannula.

Examples of various needle insertion tools are described in, but are notlimited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; U.S. patent application Ser. No. 11/645,435, filedDec. 26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method,” all of which are herein incorporated byreference in their entirety. Thus, in such examples, the sensor 1111 maybe activated, for example, before or after, the first housing portion1101 and the second housing portion 1102 are brought operativelyengaged.

The second housing portion 1102 may include a magnetic source 1121 orthe like for providing a certain gauss level. The magnetic source 1121may be similar to the magnetic source 1120 previously described or anyof the magnetic sources described in, but is not limited to, U.S. patentapplication Ser. No. 12/649,619, filed Dec. 30, 2009, entitled“Alignment Systems and Methods,” herein incorporated by reference in itsentirety.

The magnetic source 1121 may be arranged on or in the second housingportion 1102 at a location to allow the gauss level of the magneticsource 1121 to be detectable and/or measurable by the sensor 1110 in acase where the first housing portion and the second housing portion 1102are connected properly. Detection of gauss level of the magnetic source1121 may indicate that the first housing portion 1101 and the secondhousing portion 1102 have been connected properly. In furtherembodiments, the sensor 1111 and/or associated electronics may beconfigured to detect a gauss level that is within a specified range. Insuch embodiments, a gauss level that is below or exceeds the specifiedrange may indicate an improper connection.

In some embodiments, the magnetic source 1121 may be in contact with thesensor 1111 to allow the sensor 1111 to detect the gauss level of themagnetic source 1121. In other embodiments, the magnetic source 1121need not be in contact with the sensor 1111 to allow the sensor 1111 todetect the gauss level of the magnetic source 1121. For example, aportion of one or both of the first housing portion 1101 and the secondhousing portion 1102 may be arranged between the sensor 1111 and themagnetic source 1121.

Furthermore, the sensor 1111 and the magnetic source 1121 may bearranged such that in a case where the first housing portion 1101 andthe second housing portion 1102 are not been properly connected, thesensor 1111 will not be able to detect the gauss level (or the gausslevel is not within a detectable range) of the magnetic source 1121, forexample, because the sensor 1111 and the magnetic source 1121 are toofar apart. Accordingly, this may indicate that the first housing portion1101 and the second housing portion 1102 have not been connectedproperly.

In further embodiments, electronics (not shown), such as a magneticthreshold switch (e.g., hall switch, reed switch, and/or the like), orthe like, associated with the sensor 1111 may be configured to provide asignal or the like upon the sensor 1111 (or other sensor) sensing asignal outside a second range, which in some embodiments may be the samethe specified range. In other embodiments, the second range may bedifferent from the specified range. For example, the electronics mayprovide a signal to the control electronics of the medical device system1100 to disable the medical device system 1100 or certain portionsthereof if a gauss level beyond the second range is detected. Suchembodiments may protect the various electronics of the medical devicesystem 1100 in a case where the medical device system 1100 is inoperation and is exposed to a strong external magnetic influence, suchas an Mill (magnetic resonance imaging) machine, or the like.

In some embodiments, the magnetic source 1121 may provide more than onegauss level. In such embodiments, the sensor 1111 may be configured todetect only a particular gauss level corresponding to a properconnection of the first housing portion 1101 and the second housingportion 1102 similar to a manner previously described. Thus, detectionof the particular gauss level may indicate that the first housingportion 1101 and the second housing portion 1102 have been connectedproperly. In further embodiments, the sensor 1111 may be configured todetect other gauss levels such that detection of the other gauss levelsmay indicate an improper connection of the first housing portion 1101and the second housing portion 1102. The electronics may employ analgorithm for processing information relating to the various gausslevels and/or other related information (e.g., magnetic field strength,direction of a field, and/or the like).

With reference to FIGS. 45A-45B, in various embodiments, the sensor 1110and the sensor 1111 may be the same sensor and thus may be configured tosense both a direction of magnetic field and a gauss level from amagnetic source. In some embodiments, the sensor 1110 and the sensor1111 may both provided for sensing a magnetic source (e.g., 1120, 1121)as previously described. The sensor 1110 and the sensor 1111 may bearranged to sense the same magnetic source or respective magneticsources. In further embodiments, the electronics may employ an algorithmfor processing information relating to the various gauss levels, fielddirections, and/or other related information.

In various embodiments, the sensor 1110, 1111 may be provided on thefirst housing portion 1101 and the magnetic source 1120, 1121 may beprovided on the second housing portion 1102. In other embodiments, thesensor 1110, 1111 may be provided on the second housing portion 1102 andthe magnetic source 1120, 1121 may be provided on the first housingportion 1101. In further embodiments, each of the first housing portion1101 and the second housing portion 1102 may be provided with a sensor(e.g., 1110, 1111) and complementing magnetic source (e.g., 1120, 1121).

With reference to FIGS. 41A-45B and 48, the sensors and/or theelectrical contacts may be in electrical communication with electronics(not shown). The electronics may be incorporated within controlelectronics for controlling a drive device 44 (e.g., FIG. 4) such as,but not limited to, control electronics 52 (e.g., FIG. 4) forcontrolling the drive device 44. Alternatively, the electronics may beseparate from and in addition to the control electronics 52, butconnected in electrical communication with the control electronics 52and/or the drive device 44 to provide a drive control signal to thedrive device 44. More specifically, the electronics may be configured toinhibit operation of the drive device 44, unless a signal or a change instate is received by the control electronics 52.

For instance, as previously discussed, a signal or a change in state maybe provided upon the first end 922 and the second end 924 interactingwith the first main contact 912 and the second main contact 916, forexample, in a case where the first housing portion 901 and the secondhousing portion 902 are in proper alignment and sufficiently close inproximity to connect for operation. In other words, the drive device 44may be inoperable unless the first housing portion 901 and the secondhousing portion 902 are operatively engaged properly (i.e., alignedand/or connected properly).

The electronics and/or the control electronics 52 (e.g., FIG. 4) may beconfigured to control the drive device 44 (e.g., FIG. 4) in variousmanners in accordance with various embodiments of the invention.Examples are discussed in, but are not limited to, U.S. patentapplication Ser. No. 11/759,725, entitled “Infusion Medium DeliveryDevice and Method with Drive Device for Driving Plunger in Reservoir”;and U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009,entitled “Alignment Systems and Methods,” both of which are hereinincorporated by reference in their entirety.

For example, the drive device 44 may be controlled to stop pumping(delivery) operation upon a detection of an interruption of a fluid-flowpath or a disconnection of a critical component in the medical devicesystem (e.g., 900, 1100). These may include, but are not limited to, adisconnection of a housing portion from another housing portion or froma base portion, a disconnection of a conduit from another conduit orfrom a reservoir, a disconnection of a reservoir from a housing portionor a base, and/or the like.

In yet further embodiments, additional sensors may be provided withinthe medical device system and connected for electrical communicationwith the electronics 414. Such additional sensors may comprisemagnetically and/or electronically actuating switches, magnetic and/orelectric field magnitude and direction sensors, inductive sensors, otherproximity sensors, contact sensors, and/or the like for providing adetectable signal or change in a state upon proper connection of othercomponents in the medical device system. Such proper connection of othercomponents may comprise, for example, one or more of a proper connectionof a reservoir into a housing portion or base, a proper connection of aconduit to a reservoir, a proper connection of two conduits together, aproper setting of a needle or cannula in an inserted state, a properconnection of a conduit to a cannula or needle, or a proper connectionof other components of or to the medical device system.

In alternative or in addition, the electronics and/or the controlelectronics 52 (e.g., FIG. 4) may be configured to detect a first-timeconnection of a first housing portion (e.g., 901) and a second housingportion (e.g., 902) or a first-time connection of other components, ascompared to a re-connection after previous or partial usage. In thismanner, the drive device 44 may be controlled to provide a primingoperation or other suitable first-time operation(s) upon detection of afirst-time connection of the first part 401 and the second part 402.

In various embodiments, the sensors, electrical contacts, and/orassociated circuitry may allow for, but is not limited to, tracking anumber of times a component has been connected to and/or disconnectedfrom other components, verifying proper connection and/or alignment ofcomponents in a medication delivery system prior to each delivery step,checking, sensing, and/or measuring parameters, such as ambientparameters (e.g., ambient magnetic fields), operating parameters, and/orthe like, alerting users to conditions, such as conditions outsideoperating parameters of the delivery system, and/or the like.

Various embodiments may allow for verification between two (or more)distinct and separate components, verification of correct positioningbetween the two (or more) distinct and separate components, verificationthat the two (or more) distinct and separate components have beenconnected in the correct order, a safety mechanism to providenotification of separation (intentional or accidental) of any individualcomponent in a multi-component system, and/or the like.

In alternative or in addition, the electronics and/or the controlelectronics 52 (e.g., FIG. 4) may be configured to provide auser-perceptible indication of a proper alignment and/or connection ofthe first housing portion and the second housing portion or of othercomponents. For example, upon detection of a proper alignment and/orconnection of the first housing portion and the second housing portion402, the electronics 414 and/or the control electronics 52 may provide asuitable control signal to activate an indicator device 420, as shown inFIG. 36.

The indicator device 420 may be operated by a processor 422. Theprocessor 422 may be configured to execute various programs and/or toprocess various information, such as data received from one or moresensors, responsive devices, and/or other interactive elements. Theprocessor 422, for example, may be configured to compare detectedsignals with thresholds and/or pre-stored values in memory 424.

With reference to FIGS. 41A-45B and 48, the indicator device 420 mayinclude, but is not limited to, an audible indicator, an opticalindicator, a tactile indicator, combinations of one or more thoseindicators, and/or the like. For example, upon a proper alignment orconnection of components as described above, an audible beeping sound orother suitable sound may be generated by a sound generating device in orassociated with one or both of the first housing portion and the secondhousing portion. For example, upon a proper alignment or connection ofcomponents as described above, a flashing light or other suitable visualindicator may be generated by an LED or other light source or a displaydevice on or associated with one or both of the first housing portionand the second housing portion. For example, upon a proper alignment orconnection of components as described above, a vibration and/or the likemay be generated by a vibration device and/or the like in or associatedwith one or both of the first housing portion and the second housingportion. Examples of indicator devices are discussed in, but are notlimited to, U.S. patent application Ser. No. 11/759,725, entitled“Infusion Medium Delivery Device and Method with Drive Device forDriving Plunger in Reservoir”; and U.S. patent application Ser. No.12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems andMethods,” both of which are herein incorporated by reference in theirentirety.

FIGS. 46A-47C illustrate a medical device system 600 according tovarious embodiments of the present intention. The medical device system600 may include features similar or may be employed as an embodiment ofthe medical device system 100 (e.g., FIGS. 7-23, the medical devicesystem 200 (e.g., FIGS. 16-19), the medical device system 300 (e.g.,FIGS. 20-23), the medical device system 400 (e.g., FIGS. 24-29B), themedical device system 500 (e.g., FIGS. 30A-40B), the medical devicesystem 900, (e.g., FIGS. 41A-43B), the medical device system 1100 (e.g.,FIGS. 44A-45B), and/or any of the other embodiments described in thedisclosure. Although the medical device system 600 may include featuressimilar or used with the embodiments of FIGS. 7-45B, it should beunderstood that the medical device system 600 may also include some orall of the same features and operate in a manner similar to that shownand described in the embodiments of FIGS. 1-6C and 48-59B. In addition,some or all of the features shown in FIGS. 1-45B and 48-59B (and/or anyof the other embodiments described in the disclosure) may be combined invarious ways and included in the embodiments shown in FIGS. 46A-47C.Likewise, it should be understood that any of the features of theembodiments of FIGS. 46A-47C may be combined or otherwise incorporatedinto any of the other embodiments of FIGS. 46A-47C as well as any otherembodiment herein discussed.

A generalized representation of a first part 601 and a second part 602of the medical device system 600 is shown in FIGS. 46A-47C. The firstpart 601 and the second part 602 may be configured to be connectable toeach other or to be otherwise operatively engageable with each other.

The first part 601 and the second part 602 may each be one of twohousing portions, such as, but not limited to, a durable housing portion30 (e.g., FIGS. 1-6C) and a disposable housing portion 20 (e.g., FIGS.1-6C), respectively, as previously described. As previously discussedwith respect to FIGS. 1-6C, the durable housing portion 30 may includevarious components, such as, but not limited to, a drive device 80,drive motor 84, drive device linkage portion 82, and/or the like. Thedisposable housing portion 20 may include various components, such as,but not limited to, a reservoir system 40. Returning to FIGS. 46A-47C,alternatively, one of the first part 601 and the second part 602 may bea base portion 21 (e.g., FIGS. 1-6C) and the other of the first part 601and the second part 602 may be a housing portion such as, but notlimited to, the durable housing portion 30 and/or the disposable housingportion 20. In some embodiments, one of the housing portions may be ormay include a reservoir system 40 (e.g., FIGS. 1-6C).

The first part 601 and the second part 602 may be configured to engageeach other in a sliding motion (or other suitable motion) at least froma first position P1 to a second position P2. In specific embodiments,the first part 601 and the second part 602 are configured to align witheach other at the first position P1 and detect whether the first part601 and the second part 602 are properly engaged when in the secondposition P1.

In some embodiments, one of the medical device system 600 parts (e.g.,601 in FIGS. 46A-47C) may be provided with a first interactive element604, which may be similar to any of the first interactive elements(e.g., 104, 204, 304, 404, 504, etc. in FIGS. 7-29B) discussed in thedisclosure. The other medical device system 600 part (e.g., 602 in FIGS.46A-47C) may be provided with a second interactive element 606, whichmay be similar to any of the second interactive elements (e.g., 106,206, 306, 406, 506, etc. in FIGS. 7-29B) discussed in the disclosure.The first interactive element 604 and the second interactive element 606may be configured to interact with each other in a detectable mannerwhen in sufficiently close proximity to each other. As detailed in thedisclosure, interaction between the various elements, such as (but notlimited to) between the first interactive element 604 and the secondinteractive element 606, may include (but is not limited to) engaging ofthe elements, contact between the elements, application of a force(e.g., pressure) of one element on the other element, application ofenergy (e.g., electrical charge, magnetic charge, heat, etc.), and/orany suitable exchange between the elements that is detectable.

The first interactive element 604 may be arranged in a fixed relation tothe first part 601, for example, by attaching, forming, or otherwisesupporting the first interactive element 604 to a suitable location on awall or on other structure of or in the first part 601. The secondinteractive element 606 may be arranged in a fixed relation to thesecond part 602, for example, by attaching, forming, or otherwisesupporting the second interactive element 606 to a suitable location ona wall or on other structure of or in the second part 602. In someembodiments, the second interactive element 606 may be arranged on thesecond part 602 to be relative to the first interactive element 604 onthe first part 601 in a case where the first part 601 and the secondpart 602 are connected or otherwise operatively engaged and the firstpart 601 and the second part 602 are properly aligned. Accordingly, thefirst interactive element 604 and the second interactive element 606 maybe aligned. As such, the first interactive element 604 and the secondinteractive element 606, for example, may interact with each other in acase where the first part 601 and the second part 602 are connected orotherwise operatively engaged and the first interactive element 604 andthe second interactive element 606 are properly aligned.

An interaction between the first interactive element 604 and the secondinteractive element 606 (or between any other interactive elementdiscussed in the disclosure) may occur in a case where the first part601 and the second part 602 are operatively engaged properly orotherwise brought into a pre-defined, sufficiently aligned positionand/or in a pre-defined, sufficiently close proximity. The predefinedaligned position and/or proximity, for example, may correspond to aproperly aligned and mutually proximate position for connection of thefirst part 601 and the second part 602 for operation. It should beunderstood that with respect to the embodiments described in thedisclosure, operatively engaged may include connected and/or aligned,unless otherwise specified. Likewise, operatively engaged (and/orconnected and/or aligned) may include operatively engaged properly(and/or connected properly and/or aligned properly), unless otherwisespecified.

In various embodiments, the first interactive element 604 and the secondinteractive element 606 may be similar types of devices. For instance,in some embodiments, the first interactive element 604 may be configuredto interact with one or more second interactive elements and/or thesecond interactive element 606 may be configured to interact with one ormore first interactive elements. For example, a first interactiveelement 604 may be a magnet arranged to provide an N (north) polarityand a second interactive element 606 may be a magnet arranged to providean S (south) polarity. As such, the first interactive element 604 havingthe N polarity may interact more effectively (e.g., connect and/oralign) with the second interactive element 606 having the S polaritythan with another first interactive element 604 arranged to provide an Npolarity.

In some embodiments, the first interactive element 604 and the secondinteractive element 606 may be dissimilar types of mechanisms. Forexample, a first interactive element 604 may be a ferrous conduit (orother magnetically attractive material) and a second interactive element606 may be a magnet. The second interactive element 606 may interactwith (e.g., connect and/or align) the first interactive element 604, aswell as other magnetic second interactive elements 606 when theconnected or otherwise brought together along the line A1 to put thefirst part 601 and the second part 602 in the first position P1. Asanother example, for example with reference to FIGS. 15A and 15B, afirst interactive element (e.g., 104 in FIGS. 15A-15B) may be aprotrusion, pusher, finger, or other structural feature configuredand/or arranged to act upon (e.g., urge) a second interactive element(e.g., 106′ in FIGS. 15A-15B), and/or the like that may be forinteracting with (e.g., functioning as a conductor for) another secondinteractive element (e.g., 106 in FIGS. 15A-15B).

Returning to FIGS. 46A-47C, in some embodiments, suitable electronicsmay be connected to the first interactive element 604 and/or the secondinteractive element 606 to provide a controlled power signal toselectively activate or otherwise control one or more of the firstinteractive element 604 and the second interactive element 606 and/orother components as described in the disclosure.

In various embodiments, some or all of the interactive elements (e.g.,first interactive element 604, second interactive element 606) may beintegrated with the first part 601 and the second part 602 and/or beseparate components placed in or on the first part 601 and the secondpart. For example, the interactive elements may be placed in or on thefirst part 601 and the second part 602 in a friction-fitting manner,during a molding a process, and/or the like (e.g., magnetizing asuitable portion of the first part 601 and/or the second part 602). Insome embodiments, one or more of the interactive elements may be insertmold labeled on its respective part. In some embodiments, a film covermay be provided for supporting one or more of the interactive elements.

In various embodiments, some or all of the interactive elements may havean exposed surface. The exposed surface of the interactive elements maybe for allowing increased interactivity between each of the interactiveelements, for example to allow a user to locate the interactive elements(e.g., to facilitate connection of the first part 601 and the secondpart 602), and/or the like. In other embodiments, some or all of theinteractive elements may be covered, for example (but not limited to)being disposed completely within the first part 601 and/or the secondpart 602. Such embodiments may allow for protecting the interactiveelements from damage, debris collection, mitigating interference withother components (e.g., other interactive elements, electronics in themedical device system 600, and/or the like), and/or the like.

In various embodiments, the first interactive element 604 and the secondinteractive element 606 may be properly aligned such as, but not limitedto, when the first interactive element 604 and the second interactiveelement 606 align in one dimension (e.g., along the line A1) or morethan one dimension, are sufficiently proximate to each other, contacteach other, an electrical or magnetic connection is established betweenthe components, and/or the like. Any one or combination of these eventsmay occur, for example, in a case where the first part 601 and thesecond part 602 are operatively engaged and positioned relative to eachother in a predetermined manner. In other words, the first part 601 andthe second part 602 have been connected sufficiently proper and/orotherwise within an operating threshold.

In other embodiments, the first interactive element 604 may be arrangedon the first part 601 at a location to interact electronically (ormagnetically) with the second interactive element 606 in a case wherethe first part 601 and the second part 602 are brought together (e.g.,at the first position P1) and the first interactive element 604 and thesecond interactive element 606 are in relative close proximity to eachother, such as, but not limited to, in contact with each other. In someembodiments, suitable electronics may be connected to at least one ofthe first interactive element 604 and the second interactive element 606to provide a controlled power signal to selectively activate orotherwise control the first interactive element 604 and/or the secondinteractive element 606.

In some embodiments, multiple pairs of first interactive elements andsecond interactive elements may be provided on the first part 601 andthe second part 602, for example, to provide a more reliable alignmentbetween the first part 601 and the second part 602. An example of such aconfiguration is shown (but not limited to) FIG. 8. With reference toFIGS. 8 and 46A-47C, in such embodiments, a second pair of interactiveelements including a first interactive element (e.g., 104′ in FIG. 8)and a second interactive element (e.g., 106′ in FIG. 8) are supported bythe first part 601 and the second part 602 respectively in a mannersimilar to that described above for the first interactive element 604and the second interactive element 606. In further embodiments, morethan two pairs of interactive elements may be supported by the firstpart 601 and the second part 602, as previously described.

In various embodiments, the first interactive element 604 and the firstinteractive element 104′ (and/or the second interactive element 606 andthe second interactive element 106′) may be dissimilar from each. Forinstance, in some embodiments, the first interactive element 604 may beconfigured to interact with second interactive elements (e.g., thesecond interactive element 606) and/or the first interactive element104′ may be configured to interact with second interactive elements(e.g., the second interactive element 106′). For example, a firstinteractive element 604 may be a magnet arranged to provide an N (north)polarity and a second interactive element 606 may be a magnet arrangedto provide an S (south) polarity. A first interactive element 104′ maybe a magnet arranged to provide an S (south) polarity and a secondinteractive element 106′ may be a magnet arranged to provide an N(north) polarity. Thus, the first interactive element 604 having the Npolarity may interact in a more mutually attracting manner (e.g., toconnect and/or align) with the second interactive element 606 having theS polarity than the second interactive element 106′ having the Npolarity. Similarly, the first interactive element 104′ having the Spolarity may interact in a more mutually attracting manner (e.g., toconnect and/or align) with the second interactive element 106′ havingthe N polarity than the second interactive element 606 having the Spolarity.

In some embodiments, the first interactive element 604 and the firstinteractive element 104′ and/or the second interactive element 606 andthe second interactive element 106′ may be dissimilar types ofmechanisms. For example, as described with respect to, for example FIGS.15A and 15B, a first interactive element (e.g., 104 in FIGS. 15A-15B)may be a protrusion, pusher, finger, or other structural featureconfigured and/or arranged to act upon (e.g., urge) a second interactiveelement (e.g., 106′ in FIGS. 15A-15B) and/or the like arranged and/orconfigured to interact with (e.g., function as a conductive medium) asecond interactive element (e.g., 106 in FIGS. 15A-15B).

Returning to FIGS. 46A-47C, in particular embodiments, the interactiveelements (e.g., 604, 606, and/or the like) may align the first part 601and the second part 602 at the first position through magnetism. Forinstance, the first interactive element 604 may be a magnet provided onthe first part 601. The second interactive element 606 may be amagnetically attractive material, such as a magnet of opposite polarity,a metal, and/or the like provided on the second part 602. Such anexample as well as other examples are disclosed in, but are not limitedto, U.S. patent application Ser. No. 11/759,725, entitled “InfusionMedium Delivery Device and Method with Drive Device for Driving Plungerin Reservoir,” herein incorporated by reference in its entirety. Assuch, when the user-patient brings the first part 601 and the secondpart 602 sufficiently close together in the direction A1, the firstinteractive element 604 and the second interactive element 606 willinteract with each other by attracting each other. Continued movement ofthe first part 601 and the second part 602 (by the user-patient and/orthrough the magnetic attraction of the first interactive element 604 andthe second interactive element 606) in the direction A1 will properlyalign the first part 601 and the second part 602 at the first positionP1.

Thus in various embodiments, as part of a process of assembling a firstpart 601 and a second part 602 of a medical device system 600, a usermay bring the first part 601 and the second part 602 together along thedirection A1 to operatively engage each other or otherwise be insufficiently close proximity at the first position P1. Accordingly, afirst interactive element 604 and a second interactive element 606(and/or other interactive elements) may interact with each other toalign the first part 601 and the second part 602 and/or to determine,for example, whether the first part 601 and the second part 602 havebeen properly aligned.

As such, in various embodiments, the interactive elements (e.g., firstinteractive element 604, second interactive element 606, and/or thelike) may be configured to help a user-patient align the first part 601and the second part 602 relative to each other for proper connection.For example, one or more pairs of interactive element 604, 606, and/orthe like may be arranged at one or more appropriate locations on thefirst part 601 and the second part 602 to allow an indicator orindicator device 420 (e.g., FIG. 48) associated with the medical devicesystem 600 to provide an indication that the first part 601 and thesecond part 602 are properly aligned in one or more dimensions relativeto each other. Alternatively or in addition, one or more pairs ofinteractive element 604, 606, and/or the like may be of suitablesize(s), shape(s), orientation(s), and position(s) to allow an indicatorassociated with the medical device system 600 to provide an indicationthat the first part 601 and the second part 602 are properly aligned inone or more dimensions relative to each other. For example, theindicator may provide an indication that the first part 601 and thesecond part 602 are properly aligned at the first position P1 in a casewhere the first interactive element 604 and the second interactiveelement 606 interact.

In some embodiments, a conductive medium (e.g., 108 in FIG. 9) may be ata position adjacent one of the interactive element(s) (e.g., the secondinteractive element 606) or otherwise in communication with theinteractive element to allow the conductive medium 108 to function as aconductor for the interactive element. An example of such aconfiguration is shown in (but not limited to) FIG. 9. With reference toFIGS. 9 and 46A-47C, in such embodiments, the interactive element mayinteract with the conductive medium 108 to allow the conductive medium108 to be have similar characteristics or properties, though notnecessarily exactly the same characteristics or properties. For example,a magnetic second interactive element 606 may provide a magnetic chargeto a magnetic conductive medium 108 to allow the first interactiveelement 604 to interact with the magnetic conductive medium 108. Theconductive medium 108 may be made of a material, such as, but notlimited to, an electrically conductive material (e.g., metal, graphite,salt solutions, plasma, and/or the like), a magnetically attractivematerial (e.g., metal), and/or the like. In some embodiments, theconductive medium 108 may be a sufficiently high thermally conductivematerial (e.g., metal, or any other material with a thermalconductivity, for example (but not limited to), above 1), and/or thelike.

In further embodiments, the conductive medium 108 may be arranged on itsrespective part (e.g., the second part 602) to allow the interactiveelement (e.g., the second interactive element 606) interact with theother interactive element (e.g., the first interactive element 604) onthe opposing part (e.g., the first part 601) via the conductive medium108 in any of the manners described in the disclosure. For example, inparticular embodiments, the first interactive element 604 may interactwith the conductive medium 108 in a case where the first part 601 andthe second part 602 are brought together generally along the line A1.Accordingly, the first interactive element 604 and the secondinteractive element 606 may be interactable with each other via theconductive medium 108. Thus, some embodiments may allow the firstinteractive element 604 to interact with the conductive medium 108 inaddition to or alternative to the second interactive element 606. Forexample, a magnetic second interactive element 606 having a N (North)polarity may magnetize a magnetically attractive conductive medium 108,which may then interact with a first interactive element 604 having a S(South) polarity when the first part 601 and the second part 602 arebrought together (e.g., along the line A1) to align the first part 601and the second part 602.

In some embodiments, the conductive medium 108 may be arranged at aposition adjacent the other interactive element (e.g., the firstinteractive element 604) or otherwise in communication with the otherinteractive element to allow the conductive medium 108 to function as aconductor for the other interactive element. In further embodiments, theconductive medium 108 may be arranged on its respective part to allowthe other interactive element to interact with the interactive element(e.g., the second interactive element 606) on the opposing part via theconductive medium 108 in any of the manners described in the disclosure.For example, in particular embodiments, the second interactive element606 may interact with the conductive medium 108 in a case where thefirst part 601 and the second part 602 are brought together (e.g., alongthe line A1). Accordingly, the first interactive element 604 and thesecond interactive element 606 may interact with each other via theconductive medium 108. Thus, some embodiments may allow for the secondinteractive element 606 to interact with the conductive medium 108 inaddition to or alternative to the first interactive element 606. Forexample, an electrical connection between the first interactive element604 and the second interactive element 606 may be established bycontacting the conductive medium 108 (e.g., electrically conductivemedium).

In some embodiments, the indicator may be configured to provide anindication corresponding to a type of alignment, for example, that amaximum alignment or a minimum required alignment has been achievedbetween the first interactive element 604 and the second interactiveelement 606 during connection of the first part 601 and the second part602. In some embodiments, the indicator may be configured to provide anindication corresponding to various stages of alignment, for example, noalignment, alignment in one or more axes and misalignment in one oraxes, complete alignment, and/or misalignment after alignment, and/orthe like.

In various embodiments, additional structural features may be providedon one or both of the first part 601 and the second part 602 to providea mechanical alignment function when the first part 601 and the secondpart 602 are brought together along the line A1. Such additionalstructural features may include a first sloped surface (e.g., 101 a inFIGS. 7-11) on the first part 601 arranged to mate or otherwise engage acorresponding sloped surface (e.g., 102 a in FIGS. 7-11) on the secondpart 602. As the first part 601 and the second part 602 are broughttogether generally along the line A1, a misalignment of the first part601 and the second part may result in the first sloped surface 101 a andthe second sloped surface 102 a engaging each other to align the firstpart 601 and the second part 602 with continued relative motion of theparts. Accordingly, the first sloped surface 101 a and the second slopedsurface 102 a may engage each other in a position at which the firstsloped surface 101 a and the second sloped surface 102 a may sliderelative to each other toward a proper alignment position, for example,at the first position P1.

In some embodiments, multiple pairs of sloped surfaces may be providedon the first part 601 and the second part 602, for example, to providealignment in one or more directions and/or one or more dimensions. Forexample, in some embodiments, the first part 601 and the second part 602may include a second pair of sloped surfaces including a first slopedsurface (e.g., 101 b in FIG. 8) and a second sloped surface (e.g., 102 bin FIG. 8) in a manner similar to that described above for the firstsloped surface 101 a and the second sloped surface 102 a. The secondpair of sloped surfaces may have a similar or different size and/orshape than the first pair of sloped surfaces 101 a, 102 a.

In some embodiments, (such as the embodiments exemplified in FIGS. 10Aand 10B) at least one of the first part 601 and the second part 602 mayinclude one or more sloped surfaces arranged to mate with correspondingsloped surfaces on the other of the first part 601 and the second part602. In such embodiments, at least one of the one or more slopedsurfaces may be mated with one or more of the plurality of correspondingsloped surfaces so that the first part 601 and the second part 602 canbe aligned and/or connected in multiple orientations.

In further embodiments, some or all of the interacting components, suchas the first interactive element 604 and the second interactive element606, may be arranged along the first part 601 and the second part 602 toallow the first part 601 and the second part 602 to be connected and/oraligned in multiple orientations. An example of such a configuration isshown in (but not limited to) FIGS. 10A and 10B. With reference to FIGS.10A-10B and 46A-47C, in such embodiments, the second part 602 mayinclude multiple sets of second interactive elements 606 and 106′, thusallowing the first interactive element 604 to be selectively alignedwith any of the second interactive elements 606 while allowing the firstinteractive element 104′ to be aligned with at least one of the secondinteractive elements 106′. As such, the first part 601 and the secondpart 602 can be aligned and/or connected in at least a first orientation(e.g., FIG. 10A) and a second orientation (e.g., FIG. 10B). The firstorientation, for instance, may correspond to the first position P. Thesecond orientation may correspond to a different first position. Asanother example, the first part 601 may include multiple sets of firstinteractive elements 606 and multiple sets of first interactive elements104′ for allowing selective alignment with the second interactiveelement 606 and the second interactive element 106′, respectively.

Returning to FIGS. 46A-47C, in some embodiments, the interactiveelements (e.g., first interactive element 604, second interactiveelement 606, and/or the like) may be supported and/or be part of thesloped surfaces 101 a, 102 a to provide an alignment and connectionfunction as described in the disclosure. An example of such aconfiguration is shown in (but not limited to) FIG. 11. With referenceto 46A-47C, various embodiments may additionally or alternativelyinclude other suitable structural features to aid in the alignment,including, but not limited to, curved or stepped surfaces, rollersand/or the like on the first part 601 and the second part 602 that abutas the first part 601 and the second part 602 are brought together toalign the parts.

In some embodiments, one or both of the first interactive element 604and the second interactive element 606 may have a mating, sloped, orotherwise shaped surface for engaging and providing an alignmentfunction when the first part 601 and the second part 602 are broughttogether for connection. For example, with reference to FIGS. 12 and46A-47C, the first interactive element 604 may have a sloped surfaceadapted to be mated with a corresponding sloped surface of the secondinteractive element 606 (or the part supporting the second interactiveelement) in a manner similar to that described with respect to the firstsloped surface 101 a (e.g., FIGS. 7-11) and the second sloped surface102 a (e.g., FIGS. 7-11). In further embodiments, one or both of thefirst part 601 and the second part 602 may include sloped surfaces 601a, 102 a for mating with interactive elements (e.g., first interactiveelement 604, second interactive element 606) having appropriately shapedsurfaces similar to that previously described. An example of such aconfiguration is shown in (but not limited to) FIG. 13.

Returning to FIGS. 46A-47C, in various embodiments, the interactiveelements (e.g., first interactive element 604, second interactiveelement 606, and/or the like) may allow for, but is not limited to,tracking a number of times a component has been connected to and/ordisconnected from other components, verifying proper connection and/oralignment of components in a medication delivery system prior to eachdelivery step, checking, sensing, and/or measuring parameters, such asambient parameters (e.g., ambient magnetic fields), operatingparameters, and/or the like, alerting users to conditions, such asconditions outside operating parameters of the delivery system, and/orthe like.

Various embodiments may employ different arrangements of interactiveelements on the first part 601 and/or the second part 602. For instance,in embodiments in which one of the first part 601 and the second part602 is intended to be disposable (e.g., disposed of after one or aprescribed number of uses or period of use), some of the interactiveelements may be provided on the disposable part, while other interactiveelements may be provided on a durable part (i.e., not intended to bedisposed). As a result, after a period of usage, the interactiveelement(s) on the disposable part that may have attracted and collectedstray material can be disposed of with the disposable part.

On the other hand, the interactive element(s) on the durable part can besufficiently clean and free (or be cleaned) of stray material forfurther usage. In such embodiments, arranging at least some of theinteractive element(s) on the durable portion may provide certainadvantages, such as, but not limited to, being more cost-effective, forexample, by arranging interactive elements on respective parts based oncost; easier to manufacture and/or install, and/or the like. Forexample, electronics and circuitry, such as, but not limited to, asensor (e.g., FIGS. 16-23), a responsive device (e.g., FIGS. 24-29B and48), and/or other circuitry or electronics, may be arranged on thedurable part.

In yet other embodiments, arranging at least some of the interactiveelement(s) on the disposable portion may provide certain advantages,such as, but not limited to, maintenance, cost, and/or the like. Forexample, such embodiments may allow for the interactive element(s) thathave worn down, been contaminated, or otherwise collected stray materialto be disposed of with the disposable part.

Thus in various embodiments, as part of a process of assembling a firstpart 601 and a second part 602 of a medical device system 600, a usermay bring the first part 601 and the second part 602 together along thedirection A1 to operatively engage each other or otherwise be insufficiently close proximity at the first position P1. Accordingly, afirst interactive element 604 and a second interactive element 606(and/or other interactive elements) may interact with each other toalign the first part 601 and the second part 602 and/or to determine,for example, whether the first part 601 and the second part 602 havebeen properly aligned, as shown for example in FIGS. 46B and 47B.

Once the first part 601 and the second part 602 are connected orotherwise aligned at the first position P1, the first part 601 and thesecond part 602 are configured to engage each other by moving relativeto each other, for instance in the direction A2, to the second positionP2. For instance, the second part 602 may be configured to engage thefirst part 601 by sliding the second part 602 in the direction A2 to thesecond position P2, as shown for example in FIGS. 46C and 47C.

Movement of the second part 602 in the direction A2 from the firstposition to the second position P2 causes the misalignment of the firstinteractive element 604 and the second part 602 in the direction A2.Thus, in further embodiments, in a case where the alignment of the firstinteractive element 604 and the second interactive element 606 isaccomplished via magnetism, the magnet strength used should be selectedto allow properly alignment as the first part 601 and the second part602 are brought together in the direction A1, yet allow the magnets tobe misaligned when the user pushes or slides the second part 602 in thedirection A2. For instance, the attraction between the first interactiveelement 604 and the second interactive element 606 should be sufficientto allow proper alignment, yet allow a user to separate the elementswhen moving in the direction A2.

In various embodiments, the first position P1 (i.e., the position atwhich the first interactive element 604 and the second part 602 interactto indicate that the first part 601 and the second part 602 are inproper alignment when brought together in the direction A1) maycorrespond to a location on the first part 601 where movement of thesecond part 602 in the direction A2 is guided so that alignment of thefirst part 601 and the second part 602 is maintained (e.g., at least ina direction transverse to the direction A1 and A2). For instance, one ormore rails 659, ridges, other raised surfaces, or guiding structures,for example as discussed in (but not limited to) the disclosure, may bearranged on the first part 601 (and/or the second part 602) to beadjacent (or sufficiently close), for example to be in end-to-endcontact with the second part 602, to the second part 602 (and/or thefirst part 601) when the second part 602 is at the first position P1 toallow the second part 602 to be moved in the direction A2 (e.g., along alength dimension of the first part 601) without being misalignedlaterally (e.g., relative to a width dimension of the first part 601).In other embodiments, the second part 602 need not be adjacent the rails659 at the first position P1. In such embodiments, for instance, whileat the first position, the second part 602 may be positioned in anopening 657 between tapered surfaces 659 a (i.e., non-parallel to eachother) or the like. Accordingly, when the second part 602 is movedgenerally in the direction A2, if the second part 602 is misalignedlaterally (e.g., FIG. 38B), a portion of the second part 602 may contactat least one of the surfaces 659 a to guide the second part 602 towardan aligned position in the lateral direction with continued movement ofthe second part 602 in the direction A2. Examples of various guidingstructures are discussed in (but not limited to) FIGS. 30A-40B.

Returning to FIGS. 46A-47C, in some embodiments, a plurality ofinteractive elements may be provided along or near the direction A2 onone or both of the first part 601 and the second part 602 to allowcertain interactive elements to interact depending on the relativelocation of the second part 602 to the first part 601. Such embodiments,for example, allow the user (e.g., through an associated indicatordevice) to determine whether the first part 601 and the second part 602have completely engaged (e.g., the second part 602 has reached thesecond position P2), and/or otherwise determine the relative position ofthe second part 602. Examples of such arrangements, as well as otherarrangements (e.g., using mylar films) for detecting the location of onecomponent as it moves relative to another component, are disclosed in,but not limited to U.S. patent application Ser. No. 12/649,619, filedDec. 30, 2009, which is herein incorporated by reference in itsentirety.

In various further embodiments, the second part 602 may include aninteractive element, for example, as described in the disclosure, forinteracting with the first interactive element 604 when the first part601 is moved to the second position P2, as shown in FIG. 46C. Forinstance, the second part 602 may include a third interactive element606′. In some embodiments, the third interactive element 606′ may besimilar to the second interactive element 606. For instance, the secondinteractive element 606 and the third interactive element 606′ aremagnets such that the first interactive element 604 interacts (e.g., ismagnetically attracted to, detects the magnetism of the secondinteractive element 606, etc.) with the second interactive element 606at the first position P1 and interacts with the third interactiveelement 606′ at the second position P2. In other embodiments, the thirdinteractive element 606′ may be similar to the second interactiveelement 606. For instance, the second interactive element 606 may be amagnet that is magnetically attracted to a magnetic first interactiveelement 604 to align the first part 601 and the second part 602 at thefirst position P1, and the third interactive element 606′ may be asensor configured to detect the magnetic first interactive element 604when the first part 601 and the 602 are at the second position P2.

Thus, it should also be noted that the term interact may applydifferently for various interactive elements. For example, a magneticfirst interactive element 604 and a magnetic second interactive element606 may interact via magnetic attraction between the two elements whenaligning in the direction A1, and the first interactive element 604 mayinteract with the third interactive element 606′ by configuring thethird interactive element 606′ to sense or otherwise detect the positionof the first interactive element 604 when the first part 601 and thesecond part 602 are in the second position P2.

In further embodiments, the first part 601 may include an interactiveelement, for example, as described in the disclosure, for interactingwith the second interactive element 606 when the first part 601 is movedto the second position P2, as shown in FIG. 46C. For instance, thesecond part 601 may include a fourth interactive element 604′.Accordingly, in some embodiments, when in the second position P2, theremay be a first interaction between the first interactive element 604 andthe third interactive element 606′ and a second interaction between thefourth interactive element 604′ and the second interactive element 606.

In particular embodiments, the various elements may be arranged atparticular locations of the first part 601 and/or the second part 602 toincrease alignment accuracy of particular components of the first part601 and/or the second part 602. For instance, in some embodiments, thefirst interactive element 604 may be arranged on or near the fluidconduit (e.g., 524 in FIGS. 30A-31C) of the first part 601 and thesecond interactive element 606 may be arranged on or near the reservoir(e.g., connection portion 531 in FIGS. 30A-31C, septum within thereservoir, etc.). Thus, alignment of the fluid conduit relative to thereservoir can be determined.

Thus, in various embodiments, the medical device system 600 may includeany one or combination of aligning structures, connecting structures,and detecting systems for detecting alignment and/or connectiondiscussed in (but not limited to) the disclosure. For instance, in someembodiments, the medical device system 600 is configured to align and/orconnect the first part 601 and the second part 602 at the first positionP1 and to detect alignment and/or connection of the first part 601 andthe second part 602 at the second position P2. In other embodiments, themedical device system 600 is configured to align and/or connect thefirst part 601 and the second part 602 at the first position P1 and toalign and/or connect the first part 601 and the second part 602 at thesecond position P2 (or other desired position). In yet otherembodiments, the medical device system 600 is configured to detectalignment and/or connection of the first part 601 and the second part602 at the first position P1 and to detect alignment and/or connectionof the first part 601 and the second part 602 at the second position P2(or other desired position). In other further embodiments, the medicaldevice system 600 is configured to detect alignment and/or connection ofthe first part 601 and the second part 602 at the first position P1 andto align and/or connect the first part 601 and the second part 602 atthe second position P2 (or other desired position).

In further embodiments, multiple interactive elements may be employed toallow proper alignment, connection, and/or detection of such more thantwo stages. For example, the medical device system 600 may be configuredto align and/or connect the first part 601 and the second part 602 atthe first position P1, align and/or connect the first part 601 and thesecond part 602 at some point between the first position P1 and thesecond position P2 (e.g., FIG. 31B), and to detect alignment and/orconnection of the first part 601 and the second part 602 at the secondposition P2 (e.g., FIG. 31C).

In further embodiments, the medical device system 600 may include morethan two housing portions. For example, such embodiments may include,but are not limited to, a durable housing portion 30, a disposablehousing portion 20, and a base portion 21 (refer to FIGS. 1-6C). Otherhousing portions may include, but are not limited to, an insertiondevice, electronics, and/or the like.

FIGS. 49 and 50A-59B illustrate a process S1000 for aligning and/orconnecting a first housing portion 1001 (e.g., 101, 102, 201, 202, 301,302, 303, 401, 402, 530, 550, 601, 602, 901, 902, 1101, 1102 in FIGS.7-48), and a second housing portion 1002 (e.g., 101, 102, 201, 202, 301,302, 303, 401, 402, 530, 550, 601, 602, 901, 902, 1101, 1102 in FIGS.7-48) of a medical device system 1000 (e.g., 100, 200, 300, 400, 500,600, 900, 1100 in FIGS. 7-48). In particular embodiments, the firsthousing portion 1001 may be a base portion (e.g., 21 in FIGS. 1-6C) andthe second housing portion may be a durable portion (e.g., 30 in FIGS.1-6C).

With reference to FIGS. 49-50B, according to various embodiments, theprocess S1000 is an engagement sequence for aligning and connecting thebase portion 1001 to the durable portion 1002. In FIGS. 50A and 50B(which correspond to, for example (but not limited to), the embodimentsrelating to FIGS. 46A and 47A), the base portion 1001 and the durableportion 1002 are not connected.

With reference to FIGS. 49, 51A, and 51B, in step S1005, a firstinteractive element 1004 (e.g., 104, 204, 304, 404, 504, 604, etc. inFIGS. 7-29A and 46A-47C) on the base portion 1001 may be aligned with asecond interactive element 1006 (e.g., 106, 206, 306, 406, 506, 606,etc. in FIGS. 7-29A and 46A-47C) on the durable portion 1002 to provideinitial coarse longitudinal alignment of the medical device system 1000,as shown in FIGS. 51A and 51B (which correspond to, for example (but notlimited to), the embodiments relating to FIGS. 46B and 47B). Forinstance, the second interactive element 1006 may be a magnet and thefirst interactive element 1004 may be a yoke or metal for aligning withthe magnet. In further embodiments, the base portion 1001 may includefurther interactive elements 1004′ (e.g., 104′ 204′ 304′ 404′, 504′604′, etc. in FIGS. 7-29A and 46A-47C) for engaging further interactiveelements 1006′ (e.g., 106′, 206′, 306′, 406′, 506′, 606′, etc. in FIGS.7-29A and 46A-47C) on the durable portion 1002. For instance, thefurther interactive element 1004′ may be a magnet and the secondinteractive element 1006′ may be a yoke or metal for aligning with saidmagnet. Once aligned, the durable portion 1002 may be brought toward thebase portion 1001 along a direction A1. In particular embodiments, thealignment of one or more of the elements may be indicated by anindicator device, such as (but not limited to) the indicator 420 of FIG.48.

With reference to FIGS. 49, 52A, and 52B, in step S1010, one or morerails 1059 (e.g., 559 in FIGS. 37A-38C), ridges, or other raisedsurfaces on the base portion 1001 may guide the durable portion 1002 asthe durable portion 1002 is moved (relative to the base portion 1001) ina direction A2, as shown in FIGS. 52A and 52B (which correspond to, forexample (but not limited to), the embodiments relating to FIGS.37A-38C). Accordingly, in various embodiments, the rails 1059 mayprovide initial coarse horizontal alignment between the base portion1001 and durable portion 1002 at a rear of medical device system 1000.In some embodiments, the durable portion 1002 may include arms 1037,wings, or the like for engaging the rails 1059 to provide coarsevertical alignment (and prevent the housing portions from separating inthe vertical direction) between the base portion 1001 and the durableportion 1002 at the rear of the medical device system 1000 as thedurable portion 1002 is moved in the direction A2 (relative to the baseportion 1001).

Returning to FIGS. 49, 52A, and 52B, in some embodiments, in step S1015,at least one arm 1054 (e.g., 554 in FIGS. 37A-38C), rail, or otherraised surface at or near a front end of the base portion 1001 mayengage an arm 1032 (e.g., 532 in FIGS. 37A-38C) or the like at or on afront end of the durable portion 1002 to provide a coarse horizontaland/or vertical engagement of the base portion 1001 and the durableportion 1002 toward the front end of the medical device system 1000, asshown in FIGS. 52A and 52B (which correspond to, for example (but notlimited to), the embodiments relating to FIGS. 37A-38C). In FIGS. 52Aand 52B, steps S1010 and S1015 of FIG. 49 are shown as occurringsubstantially simultaneously. In other embodiments, step S1010 may occurbefore step S1015. In yet other embodiments, step S1015 may occur beforestep S1010. In some embodiments, one or more of steps S1010 and S1015may be omitted.

With reference to FIGS. 49, 53A, and 53B, in step S1020, with continuedmovement in the direction A2, a needle 1024 (e.g., fluid conduit 524 inFIGS. 30B, 31A and 31B) in the base portion 1001 is aligned (e.g.,longitudinally, horizontally, and/or vertically) with a reservoir (e.g.,reservoir housing 508 in FIG. 30B) in the durable portion 1002 to allowthe needle 1024 to enter the reservoir to form a fluid connectiontherebetween (step S1030), as shown in FIGS. 53A and 53B. Returning toFIGS. 49, 53A, and 53B, such embodiments may provide finer alignmentthan the coarse alignment of steps S1005-S1015. Examples of structuresfor guiding the needle 1024 and/or the reservoir toward each other toform a fluid connection therebetween is disclosed in (but not limitedto) U.S. patent application Ser. No. 12/974,106, filed Dec. 21, 2010,and U.S. patent application Ser. No. 12/974,117, filed Dec. 21, 2010,both of which are herein incorporated by reference in their entirety.

With reference to FIGS. 49, 54A, and 54B, in step S1025, with continuedmovement in the direction A2, a latch 1038 on the durable portion 1002contacts a catch 1067 (e.g., protrusion 567 in FIG. 33) of the baseportion 1001, as shown in FIGS. 54A and 54B (which generally correspondto, for example (but not limited to), the embodiments relating to FIGS.33 and 34). For example, in some embodiments, the latch 1038 may be atab, protrusion, or the like. The latch 1038 may be flexible orsupported on a portion of the durable portion 1002 that is flexible. Thelatch 1038 may be configured to engage a cavity 1068 (e.g., 568 in FIG.33), engagement member, and/or the like in the base portion 1001 as thedurable portion 1002 is moved in the direction A2 (relative to the baseportion 1001). The catch 1067 may be arranged on the base portion 1001to direct or flex the latch 1038 inwardly (or outwardly) as the durableportion 1002 moves (e.g., slides) in the direction A2. Continuedmovement of the durable portion 1002 in the direction A2 beyond thecatch 1067 allows the latch 1038 to flex in the opposite direction intothe cavity 1068 or an abutment or other engagement member in or definingthe cavity 1068 of the base portion 1001.

In particular embodiments, the latch 1038 may be configured to force thebase portion 1001 and the durable portion 1002 apart in a case where thebase portion 1001 and the durable portion 1002 are not properlyconnected. For example, in a case where the durable portion 1002 is notslid a sufficient distance relative to the base portion 1001 (in thedirection A2) so that the latch 1038 clears the catch 1067 and engagesthe cavity 1068, the latch 1038 is forced in the opposite direction (tothe direction A2) to further separate the base portion 1001 and thedurable portion 1002. Accordingly, one or more of the engagement steps(e.g., steps S1005-S1045) may be repeated until the latch 1038 clearsthe catch 1067 and engages the cavity 1068 (e.g., step S1050).

With reference to FIGS. 49, 55A, and 55B, in step S1030, with continuedmovement in the direction A2, a dovetail 1042 (e.g., 542 in FIGS.35A-36B) of the durable portion 1002 engages a groove 1062 (e.g., 562 inFIGS. 35A-36B) in the base portion 1001 to provide fine vertical (and/orother) alignment between the base portion 1001 and the durable portion1002 at the rear of the medical device system 1000, as shown for examplein FIGS. 55A and 55B (which correspond to, for example (but not limitedto), the embodiments relating to FIGS. 35A-36B). Such embodiments, forinstance, may provide finer alignment than the coarse alignment of stepsS1005-S1015 (FIG. 49).

With continued movement in the direction A2, in step S1035 (FIG. 49),the needle 1024 enters the reservoir supported by the durable portion1002 to establish a fluid connection between the needle 1024 and aninterior volume of the reservoir, as shown in FIGS. 56A and 56B.

With reference to FIGS. 49, 57A, and 57B, with continued movement in thedirection A2, in step S1040, contacts 1010 (e.g., electrical contacts910 in FIGS. 41A-43B) of the base portion 1001 may engage contacts 1020(e.g., shorting mechanism 920 in FIGS. 41A-43B) of the durable portion1002, which may indicate that the base portion 1001 and the durableportion 1002 have been sufficiently connected to form a fluid flow paththerebetween, as shown in FIGS. 57A and 57B (which correspond to, forexample (but not limited to), the embodiments relating to FIGS.41A-43B).

Returning to FIGS. 49, 57A, and 57B, in step S1045, a sensor 1012 (e.g.,1110 in FIGS. 44A-45B) in the durable portion 1002 may detect apredetermined magnetic field, angle, gauss level, and/or the likeprovided by a magnetic source 1022 (e.g., 1120 in FIGS. 44A-45B) of thebase portion 1001, which may indicate that the base portion 1001 and thedurable portion 1002 have been sufficiently connected to form a fluidflow path therebetween, as shown in FIGS. 57A and 57B (which correspond,for example, to the embodiments relating to FIGS. 44A-45B). In someembodiments, a sensor (e.g., sensor 1012) is in the base portion 1001 todetect a predetermined magnetic field, angle, gauss level, and/or thelike provided by a magnetic source (e.g., magnetic source 1022) in thedurable portion 1002. In particular embodiments, the magnetic source maybe one of the elements used to align the base portion 1001 and thedurable portion 1002 (e.g., step S1005).

In FIGS. 57A and 57B, steps S1040 and S1045 of FIG. 49 are shown asoccurring substantially simultaneously. In other embodiments, step S1045may occur before step S1040. In yet other embodiments, step S1040 mayoccur before step S1045. In some embodiments, one or more of steps S1040and S1045 may be omitted.

With reference to FIGS. 49, 58A, and 58B, with continued movement in thedirection A2, in step S1050, the latch 1038 clears the catch 1067 andengages the cavity 1068 (or the like), as shown in FIGS. 58A, and 58B.In various embodiments, the catch 1067 biases the latch 1038 and thedurable portion 1002 toward the front end of the base portion 1001. Inparticular embodiments, the engaging of the latch 1038 with the cavity1068 may provide audile feedback to the user to indicate a properconnection. Other suitable methods for detecting that the latch 1038 isengaged in the cavity 1068 may also be used (e.g., detecting thepresence of the latch 1038 with a sensor, or the like). In particularembodiments, the engagement of the latch and the catch 1067 and/ordetection thereof may be indicated by an indicator device, such as (butnot limited to) the indicator 420 of FIG. 48.

With reference to FIGS. 49, 59A, and 59B, with continued movement in thedirection A2, in step S1055, a stopping surface 1036 (e.g., 536 in FIGS.30C, 31C, and 32C) of the durable portion 1002 contacts a stoppingsurface 1056 (e.g., 556 in FIGS. 30C, 31C, and 32C) of the base portion1001 to prevent further movement of the durable portion 1002 in thedirection A2 (relative to the base portion 1001), as shown in FIGS. 59Aand 59B (which correspond to, for example (but not limited to), theembodiments relating to FIGS. 30C, 31C, 32C, 46C, and 47C). Suchembodiments, may allow for additional protection of components of thedurable portion 1002 (e.g., the reservoir) and/or the base portion 1002(e.g., the fluid conduit 1024) from damage due to excessive force,speed, and/or the like in connecting the base portion 1001 and thedurable portion 1002.

With reference to FIGS. 49-59B, the various components and featuresdescribed as being on or part of the base portion 1001 and the variouscomponents and features described as being on or part of the durableportion 1002 are merely exemplary. In other embodiments, some or all ofthe various components and features described as being on or part of thebase portion 1001 may be (in addition to or in alternative of) on orpart of the durable portion 1002. Likewise, in other embodiments, someor all of the various components and features described as being (inaddition to or in alternative of) on or part of the durable portion 1002may be on or part of the base portion 1001. For instance, a dovetail1042 may be arranged on the base portion 1001 to be received in a groove1062 on the durable portion 1002. As another example, a first groove maybe provided on the base portion 1001 to receive a first dovetail on thedurable portion 1002, and a second groove may be provided on the durableportion 1002 to receive a second dovetail on the base portion 1001.

In various embodiments, one or more of the various components andfeatures of the base portion 1001 and/or the durable portion 1002 may beomitted. For instance, in some embodiments, the sensor 1012 and themagnetic source 1022 may be omitted. In such embodiments, for example,fluid flow presence may be detected or otherwise determined viaengagement of the contacts 1010 and the contacts 1020 alone and/or othersuitable detection methods.

It should be noted that the process S1000 is not limited to any one orcombination of the steps S1005-S1055 are merely exemplary, as someembodiments may omit some steps and/or include additional steps.Likewise, the order of the process S1000 is not limited to anyparticular order (e.g., FIG. 49). In other embodiments, the steps may beperformed in any suitable order. For example, step S1030 (i.e., thedovetail 1042 engaging the groove 1062) may occur before step S1020(i.e., aligning the needle 1024 with the reservoir). In particularembodiments, some of the steps of the process S1000 may occursubstantially simultaneously. For example, steps S1040 (i.e., thecontacts 1010 engaging the contacts 1020) and S1045 (i.e., the sensor1012 detecting the magnetic source 1022).

In further embodiments, the medical device system 1000 may include morethan two housing portions. For example, such embodiments may include,but are not limited to, a durable housing portion 30, a disposablehousing portion 20, and a base portion 21 (refer to FIGS. 1-6C). Otherhousing portions may include, but are not limited to, an insertiondevice, electronics, and/or the like.

With reference to FIGS. 7-59B, while particular embodiments of thepresent invention have been shown and described, it will be apparent tothose skilled in the art that the invention is not limited to theparticular embodiments shown and described and that changes andmodifications may be made without departing from the spirit and scope ofthe claimed invention. For example, while embodiments described abovemay include an adhesive material and a cover film 23 (FIGS. 2 and 3),further embodiments may include a plurality of adhesive material layersalternating with a corresponding plurality of cover film layers 23 toallow the delivery device to be secured, removed and re-secured to theskin of the patient-user one or more times.

In such embodiments, a first cover film layer located at the end of thestack of alternating layers of adhesive material and cover film may beremoved to expose a first layer of adhesive material. With the firstlayer of adhesive material exposed, a medical device system (e.g., 100)(or component thereof) may be adhered to skin of a patient-user, aspreviously described. After a suitable period of usage, the medicaldevice system (or component having the adhesive) may be removed from theskin of the patient-user, for example, for servicing, re-filling,replacement of one or more components, or the like. After removal of themedical device system (or component) from the skin of the patient-user,a second cover film layer on the medical device system (or component)may be removed to expose a second layer of adhesive material. With thesecond layer of adhesive material exposed, the medical device system (orcomponent) may be secured to the same patient-user or, in certaincontexts, to a different patient-user, for further operation. Theprocess may be repeated a number of times up to the number of adhesivematerial and cover film layer pairs are included in the pluralalternating layers of adhesive material and cover film.

In addition, while various embodiments described above may include oneor more adhesive layers, each having a peelable cover layer, otherembodiments may employ a single adhesive layer having (or pluraladhesive layers, each having) a pattern of plural peelable cover layerportions. Accordingly, a patient-user may peel off one portion of thecover layer for adhering a medical device system (e.g., 100) to thepatient-user as described above, while leaving the rest of the patternof peelable cover layer portions on the adhesive. In such an embodiment,after completion of a first period of operation of the medical devicesystem and removal of the medical device system from the patient-user, asecond portion of the peelable cover layer may be removed from theadhesive layer and the medical device system may be adhered to the samepatient-user or, in certain contents, to a different patient-user for asecond period of operation.

In various embodiments, while various medical device system (e.g., 100)embodiments described above may include base portions (e.g., 21 in FIGS.1-6C) that are configured to be secured to skin of a patient-user (orother suitable surface of operation) and that extend along a lengthand/or width of the medical device system structure, other embodimentsmay employ base portions configured to be secured to the skin of thepatient-user (or other surface) and extend less than a full length orwidth dimension of the medical device system structure to minimizesurface area in contact with the patient-user (or other surface). Suchembodiments may increase comfort of the patient-user during operation ofthe medical device system. Base portions having shapes and sizesdifferent from those shown in the accompanying drawings may be employedfor additional improvements with regard to the comfort of thepatient-user and/or minimizing the surface area in contact with thepatient-user. Furthermore, as noted above, the base portion may becomposed of a flexible material that at least partially conforms to thecurvature and movement of a body of the patient-user.

In any of the above-described embodiments in which an adhesive materialis used to secure one or more medical device system (e.g., 100)components to skin of a patient-user (or other suitable surface),multiple types of adhesive materials (or multiple strengths ofadhesives) may be employed, such that a stronger adhesive may beprovided in certain areas (e.g., around the needle injection site),while a weaker adhesive may be provided in other areas. Examples ofvarious adhesive systems may be found in, but are not limited to, U.S.application Ser. No. 12/027,963, filed Feb. 7, 2008, entitled “AdhesivePatch Systems and Methods,” herein incorporated by reference in itsentirety.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

What is claimed is:
 1. A housing for a delivery system for deliveringfluidic media to a user, comprising: a first housing portion toselectively operatively engage with and disengage from a second housingportion to be carried by the user, and to support a reservoir having aninterior volume for containing the fluidic media, wherein the secondhousing portion supports a drive device such that upon the first housingportion and the second housing portion being operatively engaged, thereservoir is operatively coupled to the drive device; and a firstinteractive element supported on the first housing portion at a locationto be interactable with a second interactive element supported on thesecond housing portion, wherein the first interactive element is amagnetic material, the second interactive element is a magnetic sensor,and a field direction of the magnetic material is sensed by the magneticsensor.
 2. The housing of claim 1, wherein the second housing portionincludes circuitry to detect an interaction between the firstinteractive element and the second interactive element.
 3. The housingof claim 2, wherein the circuitry provides a signal or a change in statein response to the first housing portion and the second housing portionbeing operatively engaged and the interaction between the firstinteractive element and the second interactive element being detected.4. The housing of claim 1, further including a plunger head moveablewithin an interior volume of the reservoir along an axial direction ofthe reservoir.
 5. The housing of claim 1, wherein the first interactiveelement and the second interactive element are interactable with eachother when the first housing portion and the second housing portion areoperatively engaged and positioned relative to each other in apredetermined manner.
 6. The housing of claim 1, wherein the firsthousing portion and the second housing portion are connected together bytwist or threaded connection.
 7. The housing of claim 1, wherein thedrive device includes a motor and a drive device linkage portion.
 8. Thehousing of claim 1, wherein the first interactive element and the secondinteractive element interact with each other when in sufficiently closeproximity to each other.
 9. The housing of claim 1, wherein the firstinteractive element and the second interactive element interact witheach other when the first housing portion and the second housing portionare connected or otherwise operatively engaged and the first interactiveelement and the second interactive element are properly aligned.
 10. Thehousing of claim 1, wherein the second housing portion includeselectronics connected to the second interactive element to provide acontrolled power signal to selectively activate or otherwise control thesecond interactive element.
 11. The housing of claim 1, wherein upon thesensor detecting presence of the first interactive element, an alignmentsystem determines whether the first housing portion and the secondhousing portion have been properly connected.
 12. The housing of claim1, wherein the second housing portion includes a responsive device toprovide an electronically detectable state or signal in response to aninteraction or lack thereof between the first interactive element andthe second interactive element.
 13. The housing of claim 1, wherein aninteraction between the first interactive element and the secondinteractive element occurs where the first housing portion and thesecond housing portion are operatively engaged properly or otherwisebrought into a pre-defined, sufficiently aligned position and/or in apre-defined, sufficiently close proximity.
 14. The housing of claim 1,wherein the second housing portion includes control electronics todetect a first-time connection of the first housing portion and thesecond housing portion.
 15. The housing of claim 14, wherein a primingoperation is provided upon detection of the first-time connection.